Methods for treating eye conditions

ABSTRACT

Architectures and techniques for treating conditions of the eye, such as presbyopia, utilize sources of treatment energy, such as electromagnetic energy emitting devices, to implement non-corneal manipulations. According to these devices and methods, the sources of treatment energy are activated to direct energy onto parts of the eye, such as the conjunctiva and sclera, to treat presbyopia. The treatments can affect at least one property of the eye and enhance an accommodation of the eye.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a divisional of U.S. application Ser. No.11/413,590, filed Apr. 26, 2006 and entitled METHODS FOR TREATING EYECONDITIONS (Att. Docket B19852P), the entire contents of which arehereby incorporated by reference.

BACKGROUND OF THE INVENTION

1. Field of the Invention

The present invention relates generally to medical treatments and, moreparticularly, to methods and apparatus for treating eye disorders suchas presbyopia using energies including infrared laser, ultrasound andradio-frequency.

2. Description of Related Art

Two common opthalmologic conditions relating to focusing disorders areknown as myopia and hyperopia. Myopia, or nearsightedness, relates to aneyesight refractive abnormality whereby distant objects appear blurredas a result of rays of light entering the eye being brought to focus infront of the retina. Hyperopia, or farsightedness, on the other hand,relates to an eyesight refractive abnormality whereby near objectsappear blurred or fuzzy as a result of light rays being brought to focusbehind the retina.

One variation of hyperopia is presbyopia, which typically is associatedwith a person's lack of capacity to focus at near distances and whichtends to develop and progress with age. Regarding this progression,presbyopia is thought to advance as the eye progressively loses itsability to accommodate or focus sharply for near vision with increasingage of the person. Accordingly, the condition of presbyopia generallysignifies a universal decrease in the amplitude of accommodation of theaffected person.

Myopia and hyperopia can be treated surgically using techniquesincluding corneal interventions, such as reshaping a surface curvatureof the cornea located inside of the limbus area, and non-cornealmanipulations, such as altering properties of the sclera (which islocated outside of the limbus area), ciliary muscle, zonules, or lens.An example of the former treatment can comprise ablating the surface ofthe cornea itself to form a “multifocal” arrangement (e.g., distancevision in one eye and reading vision in another eye according to atreatment plan referred to as monovision) facilitating viewing by apatient of both near and far objects, and an example of the lattertreatment can comprise introducing kerfs into portions of the sclera tothereby increase accommodation. Non-corneal interventions typicallycomprise temporarily removing or pulling-back the patient's conjunctiva,using forceps and scissors and/or one or more of scalpels, cautery,plasma, and laser methods, followed by the actual non-cornealmanipulations (e.g., forming kerfs in the sclera). After completing thekerfs, the conjunctiva is then typically sutured back into position.

SUMMARY OF THE INVENTION

Devices and methods of the present invention for treating conditions ofthe eye, such as presbyopia, utilize sources of treatment energy, suchas electromagnetic energy emitting devices, to implement non-cornealmanipulations. According to the architectures and techniques of thepresent invention, the sources of treatment energy can be activated todirect energy onto parts of the eye, such as the conjunctiva and sclera,to treat presbyopia, wherein the energy affects at least one property ofthe eye and results in an enhancement in an accommodation of the eye.

The source of treatment energy can comprise a source of electromagneticenergy, such as a laser. In certain implementations, the laser is anErbium based, pulsed laser which emits optical energy into the sclera ofthe eye. Introduction of the treatment energy into the sclera canincrease or facilitate an increase in accommodation of the eye, therebymitigating the effects of presbyopia.

While the apparatus and method has or will be described for the sake ofgrammatical fluidity with functional explanations, it is to be expresslyunderstood that the claims, unless expressly formulated under 35 USC112, are not to be construed as necessarily limited in any way by theconstruction of “means” or “steps” limitations, but are to be accordedthe full scope of the meaning and equivalents of the definition providedby the claims under the judicial doctrine of equivalents, and in thecase where the claims are expressly formulated under 35 USC 112 are tobe accorded full statutory equivalents under 35 USC 112.

Any feature or combination of features described herein are includedwithin the scope of the present invention provided that the featuresincluded in any such combination are not mutually inconsistent as willbe apparent from the context, this specification, and the knowledge ofone skilled in the art. In addition, any feature or combination offeatures may be specifically excluded from any embodiment of the presentinvention. For purposes of summarizing the present invention, certainaspects, advantages and novel features of the present invention aredescribed. Of course, it is to be understood that not necessarily allsuch aspects, advantages or features will be embodied in any particularimplementation of the present invention. Additional advantages andaspects of the present invention are apparent in the following detaileddescription and claims that follow.

BRIEF DESCRIPTION OF THE FIGURES

FIGS. 1-4 are schematic illustrations corresponding to types ofprocedures that can be implemented to treat an eye according to firstaspects of the present invention;

FIGS. 5-14 are schematic illustrations corresponding to types ofprocedures that can be implemented to treat an eye according to secondaspects of the present invention;

FIG. 15 is a structural diagram showing a device which can be used totreat an eye according to certain aspects of the present invention;

FIGS. 16A-18 are schematic illustrations corresponding to types ofprocedures that can be implemented to treat an eye according to thirdaspects of the present invention;

FIGS. 19A-20 are schematic illustrations corresponding to types ofstructures and corresponding processes that can be implemented to treatan eye according to fourth aspects of the present invention;

FIGS. 21-23 are schematic illustrations corresponding to types ofdevices and methods that can be implemented to treat an eye according tofifth aspects of the present invention;

FIGS. 24A-24C are schematic illustrations corresponding to types ofstructures and corresponding processes that can be implemented to treatan eye according to sixth aspects of the present invention;

FIGS. 25-28B are schematic illustrations corresponding to types ofdevices and methods that can be implemented to treat an eye according toseventh aspects of the present invention;

FIGS. 29A and 29B are schematic illustrations corresponding to types ofstructures and corresponding processes that can be implemented to treatan eye according to eighth aspects of the present invention;

FIGS. 30-31B are schematic illustrations corresponding to types ofstructures and corresponding processes that can be implemented to treatan eye according to ninth aspects of the present invention;

FIGS. 32A and 32B are schematic illustrations corresponding to types ofstructures and corresponding processes that can be implemented to treatan eye according to tenth aspects of the present invention; and

FIGS. 33A and 33B are schematic illustrations corresponding to types ofstructures and corresponding processes that can be implemented to treatan eye according to eleventh aspects of the present invention.

DETAILED DESCRIPTION OF THE INVENTION

Reference will now be made in detail to the presently preferredembodiments of the invention, examples of which are illustrated in theaccompanying drawings. Wherever possible, the same or similar referencenumbers are used in the drawings and the description to refer to thesame or like parts. It should be noted that the drawings are insimplified form and are not to precise scale. In reference to thedisclosure herein, for purposes of convenience and clarity only,directional terms, such as, top, bottom, left, right, up, down, over,above, below, beneath, rear, and front, are used with respect to theaccompanying drawings. Such directional terms should not be construed tolimit the scope of the invention in any manner.

Although the disclosure herein refers to certain illustratedembodiments, it is to be understood that these embodiments are presentedby way of example and not by way of limitation. The intent of thefollowing detailed description, although discussing exemplaryembodiments, is to be construed to cover all modifications,alternatives, and equivalents of the embodiments as may fall within thespirit and scope of the invention as defined by any appended additionaldisclosure (e.g., in claims format). It is to be understood andappreciated that the process steps and structures described orincorporated by reference herein do not cover a complete process flowfor the implementations described herein. The present invention may bepracticed in conjunction with various medical devices that areconventionally used in the art, and only so much of the commonlypracticed method steps are included herein as are necessary to providean understanding of the present invention.

Any feature or combination of features described herein are includedwithin the scope of the present invention provided that the featuresincluded in any such combination are not mutually inconsistent as willbe apparent from the context, this specification, and the knowledge ofone of ordinary skill in the art.

As used herein, “accommodation” refers to the ability to change focusfrom distant objects to near objects, which ability tends to diminishwith age.

As used herein, “choroid” refers to the highly vascular layer of the eyebeneath the sclera.

As used herein, “ciliary muscle” refers to a muscular ring of tissuelocated beneath the sclera and attached to the lens via zonules.

As used herein, “conjunctiva” refers to the thin, transparent tissuecovering the outside of the sclera.

As used herein, “cornea” refers to the clear central front tissue of theeye which can be considered to be a key component of the focusingsystem.

As used herein, “cornea epithelium” refers to the outermost skin orlayer of the cornea.

As used herein, “limbus” refers to the boundary where the cornea meetsthe sclera.

As used herein, “retina” refers to the light-sensitive layer of tissuethat lines the back of the eyeball and sends visual impulses through theoptic nerve to the brain.

As used herein, “sclera” refers to the outer supporting structure, or“the white,” of the eye.

As used herein, “vitreous body” refers to the clear colorlesstransparent jelly that fills the eyeball posterior to the lens and thatis enclosed by a delicate hyaloid membrane.

As used herein, “zonules” refers to a circular assembly of radiallydirected collagenous fibers that are attached at their inner ends to thelens and at their outer ends to the ciliary muscle.

An inability of the eye to focus sharply on nearby objects, called“presbyopia,” is associated with advancing age and typically entails adecrease in accommodation. Introduction of treatment energy (e.g., laserablation), according to any of the implementations described herein, mayincrease or facilitate an increase in accommodation, thereby mitigatingeffects of presbyopia. In typical embodiments, introduction of treatmentenergy to the sclera tissue can increase the accommodation of theciliary body to thereby allow the presbyopic patient to see both nearand far.

In accordance with various aspects of the present invention, anaccommodation can be augmented via introduction of a plurality of“tissue treatments,” meaning apertures (e.g., in the form of spots) orpits formed (e.g., via ablation), or tissue areas otherwise contactedwith treatment energy to visibly or non-visibly affect the tissue areas,in one or more of, for example, the cornea, limbus, conjunctiva, sclera,ciliary muscle, lens, and/or zonules. The tissue treatments may beformed by directing treatment energy from an external location towardthe eye and/or may be formed by way of introducing an endoscopic deviceinto an intraocular vicinity of the eye to thereby deliver treatmentenergy. The delivered treatment energy may facilitate formation oftissue treatments as described herein.

Regarding augmentation of accommodation via formation of tissuetreatments in, for example, the lens, the lens may be treated (e.g.,lased or drilled) with tissue treatments (e.g., micro-apertures), takingcare to attenuate or avoid a distortion of optical characteristics ofthe lens in the process. In an exemplary implementation, sizes,arrangements, depths, and/or other characteristics of tissue treatments(e.g., micro-apertures) can be adjusted so as, for example, to increasean accommodation (e.g., flexibility) of the lens. Following treatment,the lens may be better able to change shape and focus. For instance,according to certain implementations, relatively small perforationsranging from about 1 micron to about 5 microns may be created with, forexample, a micro-drill, laser, or needle. In other instances,alternative or additional tissue treatments (e.g., micro-apertureshaving spot shapes) may be either similarly formed in the lens or formedusing means different from that used to form the mentioned tissuetreatments, in the same or different locations, at the same or otherpoints in time, and/or with the same or different sizes.

In modified embodiments, any of the tissue treatments may have sizes(e.g., maximum diameters) the same as or smaller than about 1 micronand/or larger than about 5 microns (e.g., ranging up to about 50microns, or up to about 100 microns, or more, in certainimplementations). It may be observed that, and/or measures may be takento attenuate or avoid a possibility that, with very small diameters(e.g., about 1 micron to about 5 microns) walls of the perforations maytend to collapse on themselves. Laser characteristics can be adjustedaccording, for example, to a depth and diameter of desired cuts. Forexample, apertures formed with depths of a few microns may be generatedwith relatively high power densities and/or may have relatively smalldiameters.

Micro-apertures may be formed in the lens by, for example, directingrelatively unfocused treatment energy through the pupil or iris with afocal point of the treatment energy being targeted on the lens, or theymay be generated endoscopically. According to certain implementations,the focal point can be moved (e.g., advanced distally in a directiontoward the retina) as the depth of the cut increases into the lens, inwhich case conically-shaped apertures may result, as just one example,which exemplary formations may be beneficial in certain cases. Inmodified embodiments, micro-apertures may be formed in the lensendoscopically. Endoscopic access may be achieved through, for example,the limbus. Entry also can be accomplished, for example, adjacent to orabout 1 mm from the limbus.

In certain implementations, micro-apertures may be formed in the lensadjunctive to, for example, a scleral procedure, which may involve, forexample, formation of tissue treatments in the sclera as describedherein. The tissue treatments (e.g., micro-apertures in the lens) alsomay be treated, in accordance with another aspect of the presentinvention, to affect at least one property of the tissue of the tissuetreatment. For example, calcification of the lens may be removed in avicinity of the walls and floor of a tissue treatment. Removal ofcalcium deposits from the lens may, for example, augment an elasticityof the lens and accordingly enhance an accommodation of the lens.

Low-level laser or light therapy or biostimulation of one or more partsof the eye (e.g., the lens), further, may be performed to rejuvenatetissues thereof. In a case of the lens, an elasticity, for example, ofthe lens may be increased to thereby enhance an accommodation of thelens. In such instances, the lens can be considered a target chromoform(i.e., target tissue). Generally, a wavelength of applied light energycan be aligned with a tissue type of the lens.

A type of low-level laser or light therapy or photo dynamic therapy(PDT) may be used, as another example, on or in a vicinity of (e.g., ontissue adjacent to) the ciliary muscle to rejuvenate the muscle andthereby facilitate, for example, an accommodation of the eye. Lightwavelengths of, for example, 670, 795, 819 and 980 nm may be employed intypical embodiments. A variety of light sources may be used, includinglow-level lasers and light-emitting diodes (LEDs). Continuous-wave (CW)energy or pulsed energy having a relatively high peak energy may beuseful in such ciliary muscle treatments. The ciliary muscle may bestimulated in some cases with, for example, CW energy gated, forexample, on for about 200 ms and off for about 200 ms. The stimulationmay restore the ciliary muscle to a relatively more youthful stage. Theabove low-level applications may also be applied to scleral tissuesaccording to modified embodiments, such as, for example, low-level lasertherapy being applied to the sclera for scleral rejuvenation.

Scanning can be performed with for example a relatively small spot size.A joystick may be provided to facilitate any of the scanningimplementations described herein. In other instances, a larger spot sizecan be used without scanning. Low-level light therapy may bebeneficially applied to treatment of a larger portion (e.g., arelatively large or entire area) of the sciera. Treatment powerdensities may be relatively low, being similar, for example, to powerdensities used in treatments of, e.g., tennis elbow, temporomandibularjoint (TMJ), or tendonitis, and in representative embodiments havingcharacteristics less than the following: a power density at the surfaceof the tissue being treated of about 1.47 W/cm², a power density withinthe tissue of about 0.39 W/cm², a dose of energy of about 23.6 J/cm²(for a 60 second laser exposure), and/or an energy of about 9 J withinand about 33.5 J at the surface of the tissue being treated.

In one implementation, a type of low-level laser or light therapy orphoto dynamic therapy (PDT) may be used to increase an efficacy of ortighten the zonules. Zonules may be treated endoscopically, for example,to effectively shorten their lengths. Entry may be through a peripheralcorneal or limbal area using an endoscopic laser. An anterior insertionor posterior site can be lased to cause a more direct effect on theciliary body. One procedure in accordance with the present invention maycomprise lasing the ciliary process (e.g., a portion of the ciliarymuscle that connects to the zonules) in order to make the zonules moretaut. According to one embodiment, the zonules can be stained, makingthem a target chromoform, thereby resulting in selective treatment ofthe zonules when exposed to optical energy.

According to a broad aspect of the present invention, one or more of thetissue treatments may be implemented as described herein using variousforms of treatment energy, such as one or more of electromagneticradiation (e.g., ablating optical energy, thermal optical energy, lowlevel therapeutic optical energy, or radio frequency energy),ultrasound, and magnetism, alone or in combination with acupuncture orother therapeutic interventions. Low-level therapeutic optical energyapplications are described in co-pending U.S. Provisional ApplicationNo. 60/687,256, filed Jun. 3, 2005 and entitled TISSUE TREATMENT DEVICEAND METHOD, the entire contents of which are expressly incorporatedherein by reference. Embodiments may employ, as examples, laseracupuncture, light acupuncture, laser/RF acupuncture, and the like. Inmodified embodiments, any of the tissue treatments described herein maybe formed with a cutting or piercing tool, such as a needle or scalpel,alone or in combination with any of the aforementioned tissue-treatmentgenerating implements. Typically, acupuncture may be performied once ameridian or trigger point is identified. Magnets and/or magnetismapplied in conjunction with the herein discussed techniques orultrasound may be beneficial as well. In particular, tissue rejuvenationmay employ ultrasound, RF, laser, light, and/or magnets appliedindividually or in combination. Ultrasound applied to the eye, e.g., byvarying a frequency of the ultrasound applied to eye tissue, may serveto recondition the eye.

In certain implementations of methods of the present invention, firsttissue treatments (e.g., micro-apertures placed in the lens) may beformed (e.g., lased) in one or more parts of the eye according to thedisclosure herein, as an adjunct to, for example, other (e.g.,differing) forms of refractive treatment or surgery. Such other forms,or form, of refractive treatment or surgery may comprise, for example,second treatments (e.g., second tissue treatments) formed in other waysand/or formed as described herein but in ways differing at least in partfrom, for example, one or more of the devices, methods, or timing usedto form the first tissue treatments. For example, a non-laser form ofrefractive treatment or surgery may comprise application ofradio-frequency (RF) energy to the cornea lens and/or may compriseconductive keratoplasty (CK). The CK, which may be appropriate fortreatment of mild cases of presbyopia, may, for example, introduce asmall amount of myopia into one eye so that the treated eye can be usedfor reading without corrective glasses. For instance, the temperature ofthe lens may be raised, and edges of the cornea may be manipulated toreshape the lens. Such methods may result in softening of the lens sothat an ability to change a shape of the lens may be restored. Foldablelenses, also known as hinge lenses, may also or alternatively beinserted, as another exemplary implementation.

According to another broad aspect of the present invention, tissuetreatments can be introduced into the sclera and/or ciliary muscle. Inexemplary implementations, each of the tissue treatments comprises ashape, which may resembles a dot, spot, a short dash, or other object.That is, the shape may in certain embodiments not take a form of anelongated arc or a line. For instance, a maximum length dimension of atissue treatment can range from about 0.01 mm to about 1 mm, a maximumwidth dimension can range from about 0.01 mm to about 1 mm, and amaximum depth dimension can range from about 0.01 mm up to about 5 mm(or, alternatively, up to about 1.0 mm). The shapes and locations may bedependent on the “mapping” of the eye wherein, for example, there arerigidly locations depicted by the scieral structure or the ciliary bodystructure. The eye muscles may also play a role in determining shapesand/or locations of the tissue treatments that may be required.

In certain embodiments, tissue treatments may be formed to have maximumdiameters of about 1 micron to about 100 microns, and in particularimplementations having maximum diameters of about 20 microns to about 50microns. In other implementations, which may or may not consist of orcomprise the application of ablating optical energy to the sclera, otherdefinitions or meanings for the term “tissue treatments” may apply.

One or more of the tissue treatments may be implemented using variousforms of treatment energy, such as one or more of electromagneticradiation (e.g., ablating optical energy, thermal optical energy, lowlevel therapeutic optical energy, or radio frequency energy),ultrasound, and magnetic implementations.

Regarding formation of tissue treatments using treatment energies,typical systems for providing treatment energies may comprise one ormore of an electromagnetic source such as a laser (e.g., a diode laser)having a predetermined wavelength, an ultrasound device with apredetermined pulse, a cautery device with a pre-determined setting thatinteracts with desired parts of the eye to form tissue treatments, aradiofrequency module, an ultrasonic component, and combinationsthereof. Electromagnetic energy devices may comprise, for example,lasers having all wavelengths, such as lasers having wavelengthsranging, for example, from about 0.15 microns to about 3.2 microns.Exemplary laser beam spot sizes can range from about 0.001 mm up toabout 1.0 mm (or, alternatively, up to about 2.0 mm), and exemplarylaser energy per pulse values can range from about 0.1 mJ to about 50 mJdepending on, for example, the pulse duration and the laser beam spotsize. Typical pulse laser widths may range from about 100 nanoseconds toabout 1000 microseconds. The areas to be treated can be pre traced witha vascular laser or even the long pulse Er, Cr:YSGG, or long pulseEr:YAG, to minimize any bleeding.

Particular implementations of lasers for use on, for example, the scleramay comprise Er:YAG, Er:YSGG, Er, Cr:YSGG, or CTE:YAG lasers operated atexemplary wavelengths ranging from about 2.69 microns to about 2.8microns, and about 2.94 microns; XeCl excimer lasers operated at anexemplary wavelength of about 308 nm; frequency-shifted solid statelasers operated at exemplary wavelengths of about 0.15 microns to about3.2 microns; excimer lasers of ArF operated at an exemplary wavelengthof about 93 nm; harmonic generations of Nd:YAG or Nd:YAL or Ti:sapphirelasers operated at exemplary wavelengths of about 190 nm to about 220nm; CO lasers operated at a wavelength of, for example, about 6.0microns and carbon dioxide lasers operated at a wavelength of, forexample, about 10.6 microns; diode lasers operated at exemplarywavelengths of about 0.8 microns to about 2.1 microns; gas lasersoperated at exemplary wavelengths of about 2.6 microns to about 3.2microns; and other gas or solid state lasers including flash-lamp anddiode-laser pumped lasers operated at exemplary wavelengths of about 0.5microns to about 10.6 microns; and optical parametric oscillation (OPO)lasers operated at exemplary wavelengths of about 2.6 microns to about3.2 microns.

An ultrasound device with irrigation and aspiration can be used, and maybe accompanied, for example, by a chamber maintainer, for forming orfacilitating the formation of tissue treatments. The purpose of thechamber maintainer is to assure that proper pressure is maintained inthe eye so that a prolapse or a perforation does not occur duringformation of the tissue treatments. Irrigation may include air inaddition to fluids. Fluids may comprise one or more of sterile water, ananti-bacterial composition, an anti-viral composition, and combinationsthereof. Fluids may be steroidal, or anesthesia based. Cautery devicescan also be used at predetermined settings to form or aid in formationof tissue treatments.

According to exemplary implementations of applying energy (e.g.,ablating optical energy) to tissues (e.g., the conjunctiva or sclera),any of the phrases “plurality of tissue treatments,” “tissuetreatments,” “treatments,” “tissue treatments” or “markings” can incertain embodiments refer to tissue treatment groupings and/or tissuetreatment markings corresponding to tissue treatment groupings. Any ofthese phrases can, in the same exemplary implementations and embodimentsor in others, refer to two or more tissue treatments arranged in anon-linear and non-arcuate grouping (e.g., pattern) on the tissue,and/or arranged in a plurality of non-linear and non-arcuate groupings(e.g., patterns) on the tissue. Tissue treatments or groupings of tissuetreatments may comprise random line shapes, (straight, curved, orotherwise), or may comprise line shapes (straight, curved, or otherwise)formed in a pattern that is pre-determined based on a treatmentcustomized to an area.

In other implementations, which may or may not consist of or comprisethe application of ablating optical energy to the sclera, otherdefinitions or meanings may apply. Typical embodiments can comprisegrid-like groupings of tissue treatments, wherein for example theindividual tissue treatments can be arranged in rows and columns in astaggered or non-staggered fashion. Other typical embodiments cancomprise grid-like groupings, and/or other uniform or substantiallyuniform groupings, of tissue treatments. Still further embodiments cancomprise non-uniform groupings of tissue treatments. The groupings maybe formed manually and/or with the aid of automated devices such ascomputer controlled or aided scanners known to those skilled in the art.

Regarding formation by manual means, an output, such as, for example, afiber optic tip in cases where the treatment is electromagnetic energy,may be used to focus electromagnetic (e.g., optical) energy onto forexample the conjunctiva and/or sclera in order to form tissue treatmentsto depths of, for example, about 60% to about 99% of the scierathickness (i.e., about 500 microns to 700 microns) and, in exemplaryembodiments, depths between about 90% and 99% of the sclera thickness.An exemplary implementation can comprise an Er, Cr:YSGG laser with a 600micron quartz or sapphire (contact) tip operated at 1.25 W and 2.78microns, wherein for example incisions may expand up to 2 mm width afterlaser energy is imparted with exemplary lengths of incision being about4 mm. In such exemplary implementations, distance between incisions maybe marked at 2.5 mm but may measure 2 mm post-laser treatment, anddepths can be varied depending on, for example, the patient's scleralrigidity and thickness. In other embodiments, a surgical scalpel (e.g.,diamond blade) may be used to form tissue treatments having depths aspreviously discussed in connection with fiber optic tip embodiments. Infurther embodiments, plasma technology can be used.

Regarding formation by automated scanning, typical optical systems forproviding treatment energies may comprise ablative lasers havingpredetermined wavelengths and being focused by, for example, a lenswhich is directed, for example, onto a scanner for patterning (e.g.,using a mirror) onto the patient's eye. The scanner may comprisemotorized mirrors and/or a refractive optical means such that laserenergy is delivered (e.g., scanned) to the eye in predeterminedpatterns. The scanner thus can automatically direct laser energy over,for example, the conjunctiva and/or sclera of the eye to generatepredetermined patterns and thereby form tissue treatments to depths of,for example, about 60% to about 99% of the sclera thickness (i.e., about500 to 700 microns) and, in certain exemplary embodiments, depthsbetween about 90% and 99% of the sclera thickness. Operating parametersfor the laser can be 0.75 watts to 2.0 watts with a repetition rate of 0to 100 Hz. Cautery device parameters can be technique specific, and candepend upon the use and desired application. However, depths ofpenetration in excess of 90% may remain constant. Furthermore, theoutput can vary depending upon the manufacturer of the cautery device.

One or more of various advantages may be realized throughimplementations of scanners in the context of many of the presentlydescribed embodiments, such advantages including precision,repeatability, predictability of results, uniformity of tissue treatmentsizes and/or shapes, uniformity of spacings between and/or relativepositions of tissue treatments, and speed. Moreover, scanners may beimplemented to determine surface topographies and thicknesses of variouslayers of the eye, as known to those skilled in the art. In addition,embodiments implementing scanners may further provide a benefit ofmodifiability of treatments to a given patient. For instance a groupingor groupings may be formed during only a single procedure on thepatient's eye (e.g., one surgical procedure during one patient visit)and, subsequently, should a need be presented, one or more follow-upprocedures (e.g., implemented over multiple patient visits) may beperformed on the patient's eye. These procedures may be performed in anyorder and/or sequence of sub groupings.

Precision and efficacy of tissue treatments may be enhanced when thedepth or depths of the tissue(s) being affected (e.g., depth intosciera) is/are accurately determined and controlled. In the contexts ofmanual generation of tissue treatments, a surgeon may observe a colorchange of, for example, the sciera tissue being treated to determinewhen the tissue-treatment depth reaches a desired level. In the contextof procedures on the sclera, the surgeon may, for example, cease theforming or cutting of a tissue treatment when a hue (which may be morepronounced in the context of optical ablating rather than scalpelcutting) begins to change at the bottom of the tissue treatment beingformed. A darkening of hue (e.g., to a blue, violet, or dark brown) astissue is affected (e.g., removed) at the bottom of the tissue treatmentmay indicate, for example, less remaining sciera and a greater exposureof the underlying layer (e.g., the vascularized choroid and/or ciliarymuscle), at which time the surgeon may decide to slow or stop altogetherformation of that tissue treatment or to stop formation altogether.

When scanners or other automated or semi-automated systems are used inconnection with generation of tissue treatments, the patient'ssclera-thickness can be measured, for example, pre-operatively and thetissue-treatment depth controlled accordingly. In representativeimplementations, a scanning laser, or any other known tissue layerthickness measuring device, can be used to determine and subsequentlycontrol this depth. For example, the scanning laser may work withanother optical or ultrasound device to detect the depth. Magneticdevices also may be used to the same purpose. As another alternative, asensor may determine depth by automatically detecting, for example, achange in hue while lasing. Generally, a device such as, e.g., anoptical detector, a calorimeter, an ultrasound probe, a device forgenerating and detecting electric and magnetic fields, and a tonometercan be used to measure depth of cut. In particular, a tonometer cancheck pressure, and hence flexibility, providing real-time feedback ofan estimate of depth. Although the depth measurement determined with atonometer may not be exactly the same as that measured post-healing, thetwo measurements may be highly correlated. Other methods of depthestimating include monitoring a bottom of a kerf or other topographywhile looking for bulging. Temperature changes also may provide anindication of depth, with a drastic change in temperature being anindication that an endpoint of the incision or kerf has been reached.

With reference to FIGS. 21, 22 and 23, according to certain examples, acamera 160, such as, for example, an intraocular fiber optic camera, maybe incorporated. The camera 160 may be used, for example, to provideoptical aid in conjunction with the operating site and/or to provide,for example, a determination of the incision depth in relation to thechoroid. A change of color in the ocular structure, for example, canfacilitate a determination of when the incisional appropriatepenetration level has been reached. In other embodiments, the camera 160(e.g., intraocular or extraocular) may be configured to facilitateviewing of tissue-treatment formations, real-time or post-procedure, orto facilitate automated or semi-automated control of, for example, aprocedure for forming tissue treatments. A real-time viewing example maycomprise, for example, use of an intraocular camera to facilitatereal-time subconjunctival visualization during formation of tissuetreatments (e.g., via laser ablation) in the sclera. While monitoringthe formation of a tissue-treatment using a camera, a change in colormay be automatically detected and/or visually detected by a user. A blebor perforation may occur if the level of penetration exceeds that of thechoroid structure, so it can be imperative in certain implementationsthat an “endpoint” method be established to avoid the possibility ofhypotony or a reduction in intraocular pressure.

In exemplary embodiments, the camera 160 may be secured, for example, toan output tip of a system (e.g., a laser system), which providestreatment energy, such as shown in FIGS. 21, 22 and 23, through a fiberoptic tip 165. In FIG. 21, the output tip can comprise barbs 163 forfacilitating insertion of the output tip through the conjunctiva withrelative ease but resisting removal of the barbed output tip from withinthe conjunctiva once inserted. The fiber optic camera 160 can beintegrated into the handpiece such as depicted at A1 or can branch fromthe output tip such as shown at B1. Similar constructions can beimplemented into an oval shaped output tip, as depicted in FIG. 22.Other similar constructions can comprise a fiber optic camera or fiberoptic camera lens 160 surrounding the fiber optic tip 165. According toany of the embodiments described herein, the camera 160 may comprise avisualization fiber optic leading to a remotely disposed (e.g., not onthe output tip) camera. The fiber optic may be disposed in a cannula,which further may contain one or more of a treatment-energy waveguide(e.g., a fiber optic tip), a visualization light source, a fluid outputand an aspiration source (e.g., a calibrated aspiration source). Fluids,such as liquids (e.g., water) and/or air, can be directed over a lens ofthe intraocular camera and/or across a field of view of the intraocularcamera to create a better viewing area and/or aspiration can be appliedfor removing fluids from a vicinity of the lens or field of view. Inaddition to or as an alternative to the discussed fluid and aspirationstructures and techniques for use in combination with, for example, anintraocular camera lens, water repelling coatings (e.g., Rain-X®Original Glass Treatment, made by SOPUS Products of Houston, Tx.) can beapplied to the lens for enhanced visual clarity.

According to one embodiment, washing the output tip with water operatesto clean the coated, or non-coated, intraocular camera lens. Inoutput-tip washing or other lens cleaning embodiments and/or any otherwater (e.g., sterile water) embodiments described herein, a gelled wateror viscoelastic gel (e.g., a viscous water based gel, such as viscasil®,available at www.viscasil.com), which can be transparent, may be usedalone or in combination with water or other fluids or liquids. Any ofthe mentioned embodiments implementing fluid (e.g., water) for lenscleaning may incorporate any of the methods and structures describedherein for adding fluid (e.g., water).

Tonometric techniques of depth measurement may comprise measuringpressure at a plurality (e.g. three or four) of locations on the sclerabefore a procedure is initiated. Pressure measured during the procedurethen may be interpreted according to the initial pressure, with theinterpretation providing an estimate of depth. A similar method may beapplied to techniques for depth measurement using electric fields,magnetic fields, and chemical sensing. Mechanically, a Q-tipmulti-wavelength laser device may be employed to detect depth at abottom of a cut. For example, one wavelength (i.e., color) may indicatedepth; another color may indicate vascularization related to cancergrowth. Black light may be useful in identifying whites, so one approachis to continue cutting until whites can no longer be seen. In otherembodiments, a UV light may be placed for ease of use in determining thearea to be treated while viewing the appropriate depth. Alternatively,if a wavelength is chosen that makes blue visible, then cutting maycontinue until a blue hue is observed. Summarizing, differentwavelengths of light may be sensitive to different characteristics of,for example, the sclera. These differing sensitivities may be exploitedto determine a condition of a tissue being treated (e.g., the sclera)during a procedure, the condition being different at different layers oftissue.

Alternatively, a doctor may form a test perforation through theconjunctiva and into the sclera (i.e. extract a core sample), the testproviding an indication of elasticity, rigidity, and depth of thesclera. This indication may be used to determine and refine a treatmentprocedure (i.e. type of ablation, number of ablations, their locationsand depths). Strictures in the sclera may relate to elasticity of thesclera while colors may aid in identifying components of the sclera. Acombination of the above tools including, in one example, an olfactorydetector (e.g., sniffer), can be used to determine locations andappropriate times for performing a procedure. In certain embodiments,applied in addition to as an alternative to any of the above features,patterns of tissue treatments can be determined by a device, which canmark and/or apply the tissue treatments in areas based upon a rigiditytheory wherein the tissue treatments are imparted into the sclera(using, e.g., a scanning laser) in the determined areas.

In addition to pre-operative measurements of depths of the layer orlayers being affected, depths of remaining tissue layers at the bottomsof tissue treatments may be measured during formation of the tissuetreatments (e.g., in real-time), with one or more operating parameterssuch as remaining tissue-treatment formation (e.g., cutting) time, pulsewidth, repetition rate, average power, coolant, etc., being adjusted inaccordance with the results of the real-time depth measurement. Forinstance, a pre-operative scanning measurement may determine a sclerathickness to be about 700 microns, and ½ second into the formation of atissue treatment a real-time depth measurement may indicate a remainingdepth of the sclera at the bottom of the tissue treatment being formedto be about 325 microns. It may be determined (e.g., automaticallydetermined) at that time to continue formation of the tissue treatmentfor another ½ second. This iterative process may be repeated, whereinfor example a subsequent real-time measurement of remaining-depth ofabout 100 microns may be detected ¼ second later thus triggering, forexample, a decision to continue formation for another ⅛ second.

Various combinations and implementations of depth analysis, cuttingtype, speed control, and feedback algorithms, among other parameters,may be implemented in various combinations, for monitoring andcontrolling tissue-treatment formation depths and formationcharacteristics, for obtaining, among other things, one or more ofgreater monitoring control and tissue-treatment formation accuracy. Forexample, the laser may have a tip of 600 microns and enter the“treatment tissue” to a predetermined depth as seen by ultrasoundtechnology, artemis technology, confocal microscopy, tonometry, laser,or UV light. The power will be in the range of 1.25 watts and therepetition rate of 35 Hz, but will vary with other manufacturerspecifications for their device.

Also, when scanners are used, initial steps comprising, for example,determining one or more reference points of the eye (e.g., a center ofthe pupil, one or more points on the patient's retina, triangulatedunique points on the patient's iris, and/or tissue treatments or othermarkings formed on the patient's eye at an early stage of a procedurefor the purpose of, for example, those tissue treatments being used asreference points) may be implemented so that locations of tissuetreatments may be defined and/or recorded relative to the one or morereference points for use during the initial formation of the tissuetreatments and/or for use during follow-up procedure(s) wherein tissuetreatments may be modified and/or additional tissue treatments may beformed. In accordance with one aspect, tissue treatments formed duringan initial or earlier procedure are used as reference points duringremaining steps of the initial procedure and/or for the forming ofadditional tissue treatments during follow-up procedures. For example,rigidity mapping may be implemented wherein ultrasound is used tofacilitate detection of tissue features such as a surface topography(e.g., locations of previously formed tissue treatments) for use asreference points. Also, depths of previously formed tissue treatmentsmay be detected to provide an option of, for example, augmenting depthsof one or more tissue treatments according to desired protocols. Atopography unit will map the rigidity of the scleral tissue and form agrid. The grid will be placed over the eye with the “tissue treatment”sites marked and then lased or treated by a method of removing scleraltissue.

Referring more particularly to the drawings, FIG. 1 shows a schematicplan view of the right eye of a patient, and FIG. 2 is a side-elevationview of the eye depicted in FIG. 1. In accordance with an aspect of thepresent invention, tissue treatments (e.g., groupings of tissuetreatments) may be applied to portions of, for example, surface areas ofthe sciera disposed between the superior rectus muscle, medial rectusmuscle, inferior rectus muscle, and lateral rectus muscle. A fewexemplary groupings of tissue treatments, shown as point perforations inthe illustrated examples, are shown in FIGS. 1 and 2, wherein theexemplary groupings are described in accordance with a polar coordinatesystem. Regarding the polar coordinate system, for reference, a centerpoint 36 of the eye is designated as the pole and a line 38 isdesignated as the polar axis (e.g., zero degrees).

In the illustrated embodiment of FIGS. 1 and 2, tissue treatments areapplied in a form of perforations in a treatment zone that is definedbetween an inner radial dimension 12, denoted by phantom boundary 16,and an outer radial dimension 14, denoted by phantom boundary 18. Theinner radial dimension may coincide, for example, with the limbus of theeye in typical embodiments. In representative procedures, the innerradial dimension 12 and the outer radial dimension 14 are disposed onthe sclera. According to typical implementations of the presentinvention, a distance 20 between the inner radial dimension 12 and theouter radial dimension 14 can range from about 5 mm to about 8 mm.

A portion of interest on the sclera is located approximately 3 mm fromthe limbus and extends to the lens. This portion typically is 450 to 700mm in thickness, and the perforations may be randomly delivered to thisportion. The scleral tissue above four rectus muscles (superior, medial,inferior and lateral) may or may not be treated, but the scleral areasbetween adjacent pairs of the muscles are areas that according tocertain implementations will always be treated. A first exemplarygrouping 22 is depicted disposed between the superior rectus muscle andthe lateral rectus muscle, and comprising 5 angularly-fixed groupingswherein each angularly-fixed grouping comprises 4 tissue treatments witheach being disposed at about the same angle relative to the polar axis38 but at a different radial distance from the center point 36 of theeye.

Tissue treatments of adjacent angularly-fixed groupings are notstaggered. In the present and following examples, the particulardistributions, locations and numbers of tissue treatments (e.g., 5angularly-fixed groupings each comprising 4 tissue treatments) areselected for illustration purposes and are not intended to limit thepresent invention. For example, fewer numbers of tissue treatments, suchas about 5 to about 30 tissue treatments per eye, or substantiallygreater numbers of tissue treatments, such as about 50 to about 500tissue treatments per eye, may be implemented. The tissue treatments maybe disposed in accordance with any predetermined or real-time generatedgroupings or patterns, and/or may be randomly grouped or relativelyevenly distributed in a random or patterned fashion, using treatmentenergies (e.g., from a scanning laser), according to desired preferencesor patient needs.

A second exemplary grouping 24 is depicted disposed between the lateralrectus muscle and the inferior rectus muscle, and comprising 5angularly-fixed groupings wherein each angularly-fixed groupingcomprises 4 tissue treatments with each being disposed at about the sameangle relative to the polar axis 38 but at a different radial distancefrom the center point 36. In this embodiment, tissue treatments ofadjacent angularly-fixed groupings are staggered, so that correspondingtissue treatments in adjacent angularly-fixed groupings are disposed atdifferent radial distances from the center point 36.

Third and fourth exemplary groupings 26 and 28, respectively, are shownbetween the inferior rectus muscle and the medial rectus muscle, eachcomprising 2 angularly-fixed groupings with each angularly-fixedgrouping comprising 4 tissue treatments disposed at about the same anglebut at different radial distances from a center point 36 of the eye. Inthese embodiments, the tissue treatments of adjacent angularly-fixedgroupings are staggered, so that tissue treatments in correspondingpositions of adjacent angularly-fixed groupings are disposed atdifferent radial distances from the center point 36.

According to certain aspects of the present invention wherein multipleprocedures (e.g., implemented over multiple patient visits) areimplemented to apply the tissue treatments, an initial procedure orprocedures may comprise, for example, formation of one or morerelatively sparsely-populated grouping(s) of tissue treatments, wherebyduring one or more subsequent procedures additional tissue treatmentsmay be introduced to more densely populate (and/or to change a shape of)the one or more relatively sparsely-populated groupings of tissuetreatments. For example, in one implementation the third grouping 26 maybe formed during an initial procedure followed by formation of thefourth grouping 28 in a subsequent or follow-up procedure. Adetermination may be made before the follow-up procedure that anefficacy of the third grouping 26 is sub-optimal and/or that the patientmay stand to benefit from the introduction of additional tissuetreatments, after which determination the fourth grouping 28 may beformed in a follow-up procedure. Following formation of the fourthgrouping 28, another evaluation may be made as to whether the patientmay stand to benefit from the introduction of even further tissuetreatments, and so on.

In this and other examples, the initial and follow-up groupings oftissue treatments may share parts or all of the same boundaries asdistinguished from groupings having different boundaries similar tothose exemplified by the third and fourth groupings 26 and 28. Forinstance, first parts of the third grouping 26 and fourth grouping 28may be formed during an initial procedure followed by formation ofsecond parts of the third grouping 26 and fourth grouping 28 in asubsequent or follow-up procedure. A determination may be made beforethe follow-up procedure that an efficacy of the first parts issub-optimal and/or that the patient may stand to benefit from theintroduction of second parts, after which determination the second partsof the third grouping 26 and the fourth grouping 28 may be formed in afollow-up procedure to yield, in one example, the full shapes anddistributions of the third and fourth groupings 26 and 28 depicted inFIG. 1.

According to yet another example, following formation of the secondparts, yet another evaluation can be conducted to determine whether thepatient may benefit from the introduction of for example third parts ofthe third grouping 26 and fourth grouping 28, and so on.

In various embodiments, the various groupings may take on a wide varietyof different configurations, including different shapes, distributions,and/or densities of tissue treatments. Moreover, in further embodiments,the parts, such as the first parts and second parts, may comprisedifferent configurations, such as different shapes, distributions,and/or densities of tissue treatments. In one implementation, the firstpart may comprise a configuration similar to that shown by referencenumeral 32 and the second part when added to the first part may yield agrouping such as indicated by reference numeral 30. A third part maycomprise, for example, a grouping similar to that shown by referencenumeral 30 or by reference numeral 32, so that the sum of the first,second and third parts may generate one or more groupings resembling oneor more of, for example, the third grouping 26 and the fourth grouping28.

The first grouping 22, second grouping 24, third grouping 26 and fourthgrouping 28 may be modified, combined or duplicated, in whole or inpart, in various ways, to cover portions of, as presently illustratedwith reference to FIGS. 1 and 2, the sclera between the superior rectusmuscle, medial rectus muscle, inferior rectus muscle, and lateral rectusmuscle. For example, a procedure may comprise the placement of a firstgrouping 22 between each of the open areas formed between the superiorrectus muscle, medial rectus muscle, inferior rectus muscle, and lateralrectus muscle. As another example, a procedure may comprise theplacement of a third grouping centered in each of the 4 open areasdefined between the superior rectus muscle, medial rectus muscle,inferior rectus muscle, and lateral rectus muscle.

In accordance with an aspect of the present invention, tissue treatments(e.g., groupings of tissue treatments) may be applied to all orsubstantially all of, for example, a surface area (e.g., treatment area)of the sclera, as shown in FIG. 3. According to yet another aspect ofthe present invention, tissue treatments (e.g., groupings of tissuetreatments) may be applied to portions of the sclera overlapping thesuperior rectus muscle, medial rectus muscle, inferior rectus muscle,and lateral rectus muscle, as elucidated in FIG. 4. Exemplary groupingsof tissue treatments, shown as point perforations, are shown in FIGS. 3and 4 with the exemplary groupings of FIG. 3 being described inaccordance with polar coordinates (cf. center point 36 and polar axis38) and Cartesian coordinates (cf. polar axis 38 representing an x-axisand y-axis 40) and with the exemplary groupings of FIG. 4 beingdescribed using polar coordinates (cf. center point 36 and polar axis38).

Referring more particularly to FIG. 3, all or substantially all of asurface area of, for example, a treatment area of the sclera is providedwith tissue treatments. In one representative embodiment, the treatmentarea is a treatment zone as described above in connection with FIGS. 1and 2. The tissue treatments covering the treatment area may comprise awide variety of different configurations, including different shapes,distributions, and/or densities of tissue treatments. Four exemplarydistributions, any of which may be used to cover parts or all of thetreatment area, in any permutation, combination or degree ofduplication, are elucidated in FIG. 3. The exemplary distribution 42corresponds in pattern to the first grouping 22 (FIGS. 1 and 2), and theexemplary distribution 44 corresponds in pattern to the second grouping24 (FIGS. 1 and 2). The exemplary distribution 46 comprises tissuetreatments disposed in rows substantially parallel to the x-axis 38 andcolumns substantially parallel to the y-axis 40, wherein tissuetreatments of the rows and columns are not staggered. The exemplarydistribution 48, on the other hand, comprises tissue treatments disposedin rows substantially parallel to the x-axis 38 and columnssubstantially parallel to the y-axis 40, wherein tissue treatments ofthe rows and columns are staggered.

The tissue treatments 50, 52, 54 and 56 shown in FIG. 4 are applied totreatment areas of the sclera or the conjunctiva and sclerasimultaneously, overlapping the superior rectus muscle, medial rectusmuscle, inferior rectus muscle, and lateral rectus muscle.

The conjunctiva is the first tissue that will be perforated completely,whereas the sclera will be penetrated to a depth that allows thetreatment to be ended upon detecting (e.g., viewing) the blue/brown ofthe choroids as previously described. Such treatments may vitalize,condition or provide other benefits to those muscles and/or to adjoiningstructures. For example, in embodiments wherein tissue treatmentspenetrate through or substantially into one or more of the superiorrectus muscle, medial rectus muscle, inferior rectus muscle, and lateralrectus muscle, removed or affected areas of those muscles may beinfiltrated, at least in part, with components introduced by the surgeonand/or the body.

While the tissue treatments 50, 52, 54 and 56 covering the superiorrectus muscle, medial rectus muscle, inferior rectus muscle, and lateralrectus muscle may comprise, in accordance with various embodiments, awide variety of configurations, including different shapes,distributions, and/or densities of tissue treatments, those shown inFIG. 4 correspond in pattern to the first grouping 22 (FIGS. 1 and 2).

In accordance with modified embodiments, any part or all of any of thegroupings 22, 24, 26, 28, 30, 32, 42, 44, 46, 48, 50, 52, 54 or 56, maybe formed to have non-linear (e.g., curved) or asymmetric properties orarrangements of tissue treatments. For instance, with respect to thefirst grouping 22, the exemplary 4 tissue treatments (of one or more ofthe exemplary 5 angularly-fixed groupings) may, instead of beingdisposed at about the same angle relative to the polar axis 38, bedisposed at one or more different angles relative to the polar axis 38.As another example, regarding the distribution 46 of FIG. 3, one or morerows and/or columns of tissue treatments may be disposed, instead, innon-linear or asymmetric arrangements that are, for example, parallel toneither the x-axis 38 nor the y-axis 40.

In certain embodiments, the tissue treatments are applied to portions ofboth the conjunctiva and/or the sclera. For example, one or more of thetissue treatments can be applied, for example, wholly or partiallynon-invasively to an underlying layer. In a particular implementation,one or more of the tissue treatments can be applied, wholly or partiallynon-invasively using, for example, components that focus the treatmentenergy on or into the underlying sclera rather than on the conjunctiva.

According to a more specific example, ablating optical energy can befocused using optics into the sclera so that a peak concentration of theablating optical energy occurs within the sclera and a concentration ofthe optical energy in the conjunctiva is substantially lower or, in oneembodiment, below an ablation threshold. Dye enhancing the tissue to betreated can be used, for example, to facilitate one or more of assuringthat the treatment energy (e.g., laser energy) penetrates the desiredarea wherein different colors of dye may be used, assuring that thetreatment energy (e.g., laser energy) penetrates to the appropriatepre-determined depth wherein different consistencies and colorations canbe used to this end, and allowing for better viewing of the treatmentarea wherein dyes can be used in conjunction with the appropriate lightsource for “high lighting” and the background light can be reduced forenhancement. For example, the sclera can be stained with yellow dyeallowing for the location of strictures (e.g., ciliary muscles) to behighlighted a darker yellow. In general, regarding dye enhancing of thetissue to be treated according to the present invention, dyes maytypically be red, green or dark in nature and can be used to enhance thedepth, length or width of the incision of the tissue to be treated. Suchmethods typically may be combined with treatment energies such asinfrared energy. The operating parameter can vary depending on the typeof enhancement used, type of tissue, desired depth, length and width,and the spectrum of energy used. Thus, in the context of, for instance,the preceding example, the term “non-invasively” should be interpretedto mean that portions of the conjunctiva penetrated by the treatmentenergy are not substantially affected (e.g., not ablated), or areaffected to a lesser extent than that to which the underlying sciera isaffected, by the treatment energy.

As used herein, and not merely in the context of the present example,the term “invasively” should be interpreted to mean that portions of thetissue (e.g., sclera and or any other tissues) penetrated by thetreatment energy are substantially affected (e.g., ablated) by thetreatment energy. Invasive penetration of tissue by treatment energy maygenerate, for example, a tissue treatment.

In other examples, one or more of the tissue treatments can be appliedto penetrate through the conjunctiva (e.g., to invasively penetratewherein penetrated portions of the conjunctiva are affected, such as bybeing ablated) and to treat (e.g., ablate) the sciera.

According to a particular implementation, a collimated beam of ablatingoptical energy may be directed through both the conjunctiva and through,for example, a majority or more of the thickness of the sclera, wherebytissues of both the conjunctiva and sclera are ablated along the path ofthe collimated beam. The parameter ranges can, in exemplary embodiments,be dependent upon desired, predetermined or expected wavelengths,lengths, widths and/or heights of incisions, and exemplary tissueparameters/types to be affected can include conjunctival and scleraltissue. In certain implementations, the treatment energy beam can beshaped in the form of a complete tissue treatment (e.g., elongatedkerf). A mapping will determine the location, pattern, shape andlandscape of the region acquiring the treatment based on rigidity,muscle contraction, accommodation, and ciliary body location. Thetreatment energy beam can be completed by contact or non-contact of thelaser energy in a pulse mode, or continuous mode that is proximal to thetreatment area using a fiber based or scanner based delivery system witha predetermined software pattern or template. A beam splitter may beused to disperse energy of the beam in a pattern of the treatment area.

Dye-enhancing the tissue to be treated can, for example, be implemented.Dyes can comprise, for example, red, green or other relatively darkcolors and can be used to enhance (e.g., selectively enhance byapplication to certain areas and/or selective coupling or matching oflaser types to tissue and dye types) or otherwise affect the depth,length, width or other characteristic of the incision of the tissue tobe treated. For instance, an area can be dyed for pretreatment with alaser having a wavelength that is substantially or highly absorbed byblood, wherein following (or during) the dying the coagulating laserenergy can be directed over the dyed tissue treatment areas to causecoagulation or to otherwise affect a propensity of such tissue treatmentareas to bleed during subsequent formation of the tissue treatments. Incertain embodiments, the tissue treatment markings themselves may beformed as the dyed areas. In other embodiments, the depth, length, widthor other characteristic of the incision of the tissue to be treated canbe contacted with energy from a laser having a wavelength that issubstantially or highly absorbed by blood, wherein following (or during)the contacting the coagulating laser energy can be directed over thetissue treatment areas to cause coagulation or to otherwise affect apropensity of such tissue treatment areas to bleed during subsequentformation of the tissue treatments.

According to typical implementations, steps may be incorporated toensure that pretreatment coagulating energy or subsequent ablatingenergy does not adversely affect the retina or other tissues. Suchimplementations may embody one or more of relatively low energy levels,tissues-type and/or color (using, e.g., dyes) matching with relativelyhigh-absorption wavelengths (e.g., Nd:YAG or Er, Cr:YSGG), and focusingof the energies well in front of the retina.

Any one or more of the preceding methods may be practiced or combinedwith, for example, application of infrared energy as thetreatment-energy, wherein, again, operating parameters can varydepending on one or more of the desired type of enhancement, type oftissue, depth, length, width, other characteristic, and spectrum ofenergy used.

A dimension (e.g., a cross-sectional shape or area measured in adirection transverse to a direction of propagation of the treatmentenergy) of a tissue treatment may remain relatively constant through adepth of tissue (e.g., the conjunctiva and/or sclera) or may change withdepth. For example, one or more tissue treatments may be formed to havecross-sectional shapes or areas that decrease (or, alternatively,increase) with depth into the sclera, such as would be the case, forexample, with a circular tissue treatment having a diameter thatdecreases with increasing depth into the sclera. In typicalimplementations, a tissue treatment (e.g., a conically-shaped tissuetreatment according to the preceding example) may comprise, for example,a diameter that tapers from about 0.1 to about 100 percent with each 1percent drop in depth. In a particular example, the diameter may drop byabout 1 percent for each 1 to 20 percent drop in depth. In the contextof, for example, a tissue treatment (e.g., a conically-shaped tissuetreatment) being formed in the sclera, by way of treatment energy beingdirected non-invasively through the conjunctiva, a tissue treatmentdimension (e.g., diameter) may taper within the sclera from about 1 toabout 100 percent with each 1 percent drop in depth and, in a particularexample, may drop by about 1 to about 20 percent for each 1 percent dropin depth within the sciera.

Removed or affected areas corresponding to tissue treatments may forexample be filled-in by a surgeon with any known biocompatablematerials, such as, for example, Tisseal, anti-inflammatories orantibiotics. In accordance with one aspect of the invention, removed oraffected areas corresponding to tissue treatments are at least partiallyfilled-in by the body (e.g., via the body's natural response) withsub-conjunctiva tissue which may, for example, augment a property of theeye. For example, in the case of the sclera, the new sub-conjunctivalcollagen-based tissue infiltrating a removed or affected area of thesclera may have a greater elasticity or be more flexible than theoriginal sclera tissue. The body's introduction of sub-conjunctivatissue into removed or affected areas thus may increase the flexibilityof, for example, one or more of the sclera and ciliary muscle and/orcause zonules to increase the lens accommodation. In the example ofremoved or affected areas in the sclera, new sub-conjunctival tissue in,for example, the sclera may facilitate or enhance a functionality orother property of the underlying ciliary body. Thus, in response to theeye's attempts to see near and far, an accommodation of the ciliarymuscle may, in some instances, be increased.

According to typical implementations, the scleral tissue may be treatedby directing treatment energy through the conjunctiva over the sclerawith use of laser technology, whereby as previously mentioned the scleramay be treated with treatment energy (e.g., laser energy) aimed (e.g.,focused) subconjunctivally, leaving the conjunctiva relativelyundisrupted. For example, laser energy can be directed to focus orconverge on the underlying sclera wherein, for example, the laser energyhas a relatively low power density (e.g., a large spot size) on theconjunctiva while at the same time having a relatively high powerdensity (e.g., a relatively small spot size) on the underlying sciera,and wherein the absorption rate is that of sclera tissue so that thelaser energy forms a “v” in the sclera that cuts only the sclera tissue.As will be discussed below, the conjunctiva may be rotated or torquedfrom a different site at varying degrees in order to obtain, forexample, better cosmetic effects (e.g., reduced reddening). Tissuetreatments (e.g., kerfs) employed in such procedures may be formed invarying shapes as previously mentioned. Typical shapes can include, asexamples, “u” and “v” shapes.

The kerfs may also be made wherein the center of the kerf has moretissue than the edges. Generally, a kerf can have a width that variesaccording to different rigidity factors and scleral thicknesses indifferent scleras. However, incisional scleral depths of tissuetreatments that are greater than 90% may, in certain implementations,remain constant. According to certain embodiments, an ultrasound unitcan be used to remove both conjunctival and scleral tissue. In otherembodiments, cautery can be used, for example, to improve a clarity ofthe site where tissue treatments are to be formed and/or to generate thetissue treatments. Moreover, a light having a certain color, such as ablack light, may be used to enhance a view of scleral tissue in certainembodiments.

Further, various colors may be placed in a scope (e.g., microscope) toenhance vision (e.g., surgeon discernment of features). For instance,green may allow a user to better see depth of penetration. Additionally,a tonometer may be used to detect pressure of a tissue treatment area,and/or a femtosecond laser can be used to remove or cut tissue of thetissue treatment.

One or more of the tissue treatments may be introduced with theconjunctiva in place, wherein for example the conjunctiva is left in anaturally-occurring orientation over the sclera. In such embodiments,penetration paths through/into the conjunctiva and sclera may be alignedor substantially aligned. For example, a beam of electromagnetic energymay be directed through both the undisturbed conjunctiva and through,for example, a majority or more of the thickness of the sclera. The beammay travel through the conjunctiva in a non-invasive or invasive manneras described above, whereby, in the latter case for example, tissues ofboth the conjunctiva and sclera may be ablated along the path of thebeam of electromagnetic energy.

One or more of the tissue treatments described herein may be introducedwith parts or substantially all of the conjunctiva altered (e.g.,removed, reconfigured or repositioned such as by rotating theconjunctiva, or separating and/or shifting the conjunctiva, relative tothe sciera) before or during introduction of the one or more of thetissue treatments, in any order or sequence of steps. Thus, with any ofthe implementations described herein, parts of the conjunctiva may, incertain embodiments, be manipulated while other parts are left in anaturally-occurring orientation over the sciera. In otherimplementations, parts of the conjunctiva above portions of the sclerareceiving tissue treatments may be manipulated and/or other parts of theconjunctiva above portions of the sclera receiving tissue treatments maybe left in a naturally-occurring orientation over the sclera.Furthermore, with any of the implementations described herein,substantially all of the conjunctiva may be reconfigured or repositioned(e.g., shifted or rotated about center point 36) relative to, forexample, the sclera.

Moreover, in addition, or as an alternative, to the present invention'saltering of the conjunctiva before or during application of tissuetreatments, other aspects of the present invention may compriseintroducing one or more of the tissue treatments through the conjunctivain one or more of the pre- or post-altered states of the conjunctiva.With respect to exemplary embodiments wherein the conjunctiva isrepositioned before application of treatment energy and formation oftissue treatments, once the conjunctiva is brought to (or brought backto) assume (or at least to approximate) a naturally-occurringconfiguration or orientation (or is otherwise brought to apost-treatment configuration or orientation), some or all of thepenetration paths through/into the conjunctiva and sclera are notaligned. This lack of alignment between penetration paths of theconjunctiva and sclera, or alternatively the covering-up of penetrationpaths through the sclera in embodiments wherein, for example,penetration paths are not formed in part or all of the conjunctiva, canserve to provide, for example, one or more of a sealing effect forenhanced healing and structural integrity to the affected layers.

With reference again to FIG. 1, one example of repositioning theconjunctiva can include rotating the conjunctiva, relative to thesclera, before application of the tissue treatments. The conjunctiva canbe gripped and rotated an amount, such as, for example about 1 to 2degrees, or more broadly about 1 to 90 degrees, about the center point36. In other implementations, the rotation may range from about 1 toabout 45 degrees, or more, and/or different portions of the conjunctivamay be rotated, for example, at different points in time, in differentdirections and/or in different amounts. Following such rotation, theconjunctiva may (or may not) be held in the rotated position, forexample, while some or all of the tissue treatments are applied. Afterapplication of some or all of the tissue treatments, the conjunctiva canbe moved back, to a full or partial extent, to its naturally-occurringorientation and/or can be released so that the conjunctiva moves, to afull or partial extent, back to its naturally-occurring orientation.

In other implementations, after application of some or all of the tissuetreatments, the conjunctiva can be rotated in the opposite direction toa greater extent than that to which it was first rotated, such asrotation in the counter-clockwise direction about 1 up to 90 degrees.Following any of the rotations or shifts of the conjunctiva describedherein, and/or at any intermediate step, part or all of the conjunctivabeing altered may be held using any known temporary or permanent means.

In further implementations, after application of some or all of thetissue treatments, the conjunctiva can be rotated in the oppositedirection to a greater extent than that to which it was first rotated,such as rotation in the counter-clockwise direction about 1 up to 90degrees. Following any of the rotations or shifts of the conjunctivadescribed herein, and/or at any intermediate step, part or all of theconjunctiva being altered may be held with any known temporary orpermanent means as previously mentioned.

In other implementations, following an initial rotation of theconjunctiva, application of one or more tissue treatments (e.g., atissue treatment in the shape of a radially-extending line or a row oftissue treatments forming the line) can be made through one or moretissue treatments (e.g., elongate kerf(s) or apertures) in theconjunctiva. The conjunctiva can then be rotated in the same directionto a greater extent than that to which it was first rotated. Then, oneor more tissue treatments (e.g., a tissue treatment in the shape of aradially-extending line or a row of tissue treatments forming the line)can again be formed in the sclera through the same tissue treatmentsalready formed in the conjunctiva so that the conjunctiva is minimallyimpacted. The process can be repeated to form additional tissuetreatments of, for example, the same shape in the sclera, through thesame tissue treatments already formed in the conjunctiva. In thisexample, the conjunctiva is progressively rotated in one direction withtissue treatments being formed through the same opening(s) in theconjunctiva at each step. In modified embodiments, the conjunctiva canbe rotated in the opposite direction (e.g., past the original,naturally-occurring orientation) to various degrees to facilitateformation of one or more tissue treatments (e.g., a tissue treatment inthe shape of a radially-extending line or a row of tissue treatmentsforming the line) in the sclera through the same tissue treatmentsalready formed in the conjunctiva so that the conjunctiva is minimallyimpacted again. Accordingly, the conjunctiva can be rotated in bothdirections to facilitate formation of various tissue treatments in thesciera, all through the same opening (e.g., tissue treatment) in theconjunctiva. As a result of the reduced number of tissue treatmentsbeing formed in the conjunctiva, redness and/or healing time can beattenuated or eliminated.

FIGS. 5-14 illustrate various implementations of methods forrepositioning (e.g., rotating) the conjunctiva relative to the sclera.The tissue treatments in the conjunctiva and/or sclera can comprise, forexample, elongated or aperture-shaped tissue treatments such as thoseshown in the present examples of FIGS. 5-14, and/or may comprisegroupings of tissue-treatments as discussed in any of thepreviously-mentioned examples, or combinations and permutations thereof,in various positions, shapes and patterns (e.g., fewer or greaternumbers of elongated tissue treatments, of the same or different lengthsas those shown, at for example one or more of 0, 90, 180, and 270degrees). For instance, one or more (e.g., each) of the showntissue-treatment elongated shapes may comprise, instead of an elongatedkerf as shown, a series of smaller tissue treatments forming the samegeneral shape (cf. grouping 30 or grouping 32 of FIG. 3). Moreover, oneor more of the tissue treatments in the conjunctiva may comprise varying(e.g., reduced) sizes relative to the corresponding tissue treatmentsformed therebeneath in the sclera, as elucidated in the illustratedexamples of FIGS. 7-10, 12 and 14.

With particular reference to FIGS. 5 a-5 e, this sequence depicts arotation process wherein tissue treatments are marked, for example, at0, 90, 180, and 270 degrees. In FIG. 5 a, locations for formation oftissue treatments are marked on the conjunctiva, and in FIG. 5 b theconjunctiva is moved (e.g., rotated or torqued) or shifted in some wayor to some degree. The conjunctiva can, for example, be contacted (e.g.,gripped) using a conjunctival template device and moved.

FIG. 5 c shows that tissue treatments can then be formed in both theconjunctiva and sciera at locations corresponding to the post-movementpositions of the markings, and in FIG. 5 d the conjunctiva can onceagain be moved (e.g., rotated, torqued and/or shifted) in some way or tosome degree. For example, the conjunctiva can be moved (e.g., rotated,torqued and/or shifted) in some way or to some degree so that the tissuetreatments formed in the sclera are at least partially, and in certainembodiments, completely, covered by non-tissue-treatment areas of theconjunctiva. According to certain embodiments, the conjunctiva can bemoved back (to the same, lesser or greater extent) in a direction fromwhich it was first moved, but in modified embodiments it may be moved atleast in part (to the same, lesser or greater extent) in otherdirections. As presently embodied, the conjunctiva can be rotated sothat the angular locations of the markings are changed from theirpost-movement angular positions, and in the illustrated example of FIG.5 d the conjunctiva is rotated so that angular locations of the markingsare changed back to locations corresponding to the pre-movementpositions of the markings corresponding for example to thenaturally-occurring orientation of the conjunctiva. The conjunctiva canbe moved using for example the conjunctival template device. Followingany of the movements of the conjunctiva described herein, and/or at anyintermediate step, part or all of the conjunctiva being altered may beheld with any herein-described or known temporary or permanent means,such as the conjunctival template device.

In certain embodiments, fluids, including water, sterile water orconditioned fluids, such as described in U.S. Pat. Nos. 5,785,521 and6,350,123, the contents of which are incorporated herein by reference,may be added to ensure or aid in the cosmetic appeal of the treatedtissue and/or to assist with healing time or other properties. Forexample, fluid (e.g., sterile water) may be applied by way of a smallair mister (e.g., from a local or remotely-disposed canister or dropper)affixed, for example, to a device (e.g., an applinator device or outputtip), between or, preferably, during application of treatment energies,to thereby attenuate or eliminate charring and/or wash away blood.

As another example, fluid (e.g., sterile water) may be applied by way ofa small air mister or sprayer line affixed, for example, to a treatmentenergy (e.g., laser) device (e.g., handpiece) at or for any of theabove-noted times or purposes. The line may comprise, for example,tubing (e.g., clip-on and/or silicone based tubing) secured to anoutside or built into the device and a fluid dispensing input disposedon the device. The fluid-dispensing input may be activated, for example,to facilitate manual or powered dispensation of fluid. Manualdispensation may be implemented by way of, for example, a line leadingto or integrally formed with a detachable container (e.g., pod) that canbe squeezed by a user to dispense fluid (e.g., sterile waterpre-packaged into a single-use, disposable pod), and powereddispensation may be implemented by way of a toggle button to initiate apowered output of fluid at, for example, a relatively low flow rate andpressure. An atomized distribution of fluid (e.g., sterile water)particles may be automatically applied to the target tissue duringapplication of treatment energies, for example. In other examples, adrop of the fluid (e.g., sterile water) may be applied before or duringapplication of treatment energies. In still further embodiments,treatment energies and fluid (e.g., sterile water) may be combined tofacilitate electromagnetically induced mechanical cutting, as describedin the preceding two patents, to enhance cutting attributes. Suction maybe applied to any of the foregoing implementations, as well, forremoving fluids, debris and/or liquids. For any embodiments employingsuction for any purpose described herein, such as to secure a structureto a surface of the eye, specialized surfaces (e.g., relativelynonporous surfaces to facilitate suctional gripping and securement ofthe structure to the eye) and/or surface treatments (e.g., theabove-mentioned viscasile) can be employed.

As shown in FIG. 5 e, the tissue treatments in the conjunctiva may beclosed using techniques known in the art such as sutures, surgicaltacks, screws or staples, and/or applinator-style attachments includingadhesives. In modified embodiments, one or more of the steps shown inFIGS. 5 b and 5 d, and/or the closure step of FIG. 5 e, for example, maybe attenuated, enhanced, or omitted, in whole or in part.

Referring to FIGS. 6 a-6 e, a rotation process is shown wherein tissuetreatment markings are formed on the conjunctiva at the exemplarylocations of zero, ninety, one hundred and eighty, and two hundred andseventy degrees. As depicted in FIG. 6 a, the locations for generationof tissue treatments can be disposed on the conjunctiva in sets (e.g.,pairs). One or more (e.g., all) of the sets can comprise, for example, aplurality of tissue treatments or tissue treatment groupings asdescribed above, wherein the tissue treatments or tissue treatmentgroupings of one or more of the sets are configured to allowinterweaving with one or more of the subsequently formed tissuetreatments or tissue treatment groupings in the sclera. In theillustrated embodiment, the tissue treatments or tissue treatmentgroupings of the sets allow interweaving with the subsequently formedtissue treatments or tissue treatment groupings in the sclera (cf. FIG.6 d, infra). As presently shown, the tissue treatments or tissuetreatment groupings of each set are spaced one from the other atdifferent (e.g., greater) distances than for example those shown in FIG.5 a.

In FIG. 6 b the conjunctiva is moved (e.g., rotated or torqued) orshifted in some way or to some degree as described above. Theconjunctiva can for example be contacted (e.g., gripped) using aconjunctival template device and moved as described above. Theconjunctiva can be rotated so that angular locations of the markings arechanged from their pre-movement marked angular positions and, aspresently illustrated, so that the post-movement angular location(s) ofat least one of the markings of each set is disposed between two of thepre-movement locations of the markings of a corresponding set. Accordingto the implementation illustrated in FIG. 6 b, the post-movement angularlocation one of the markings of each set is disposed between two of thepre-movement marking locations of the corresponding set. In FIG. 6 c thetissue treatments can be formed in both the conjunctiva and sclera atlocations corresponding to the post-movement positions of the markingsas described above, and in FIG. 6 d the conjunctiva can be moved asdescribed above and the tissue treatments in the conjunctiva closed asdiscussed above and depicted in FIG. 5 e. Modified embodiments similarto those discussed above in connection with FIGS. 5 a-5 e may beimplemented, as well.

Referring to FIGS. 7 a-7 d, a rotation process is shown wherein tissuetreatment markings are formed on the conjunctiva at the exemplarylocations of zero, ninety, one hundred and eighty, and two hundred andseventy degrees. As depicted in FIG. 7 a, the locations for generationof tissue treatments can be disposed on the conjunctiva in sets (e.g.,pairs). One or more (e.g., all) of the sets can comprise, for example, aplurality of tissue treatments or tissue treatment groupings asdescribed above, wherein the tissue treatment markings (and/or tissuetreatments) in the conjunctiva comprise reduced sizes relative to thecorresponding tissue treatment markings (and/or tissue treatments) of,for example, FIG. 1. According to another aspect, the tissue treatmentmarkings (and/or tissue treatments) in the conjunctiva comprise reducedsizes relative to corresponding tissue treatments that will be formedtherebeneath in the sclera, as elucidated in the illustrated examples ofFIGS. 7-10, 12 and 14. In the illustrated embodiment, each tissuetreatment marking (and/or tissue treatment) comprises a single apertureshape disposed at each angular location (e.g., each post-movementangular location) where a corresponding tissue treatment or tissuetreatment grouping will be formed in the sclera.

In FIG. 7 b the conjunctiva is moved (e.g., rotated or torqued) orshifted in some way or to some degree as described above. Theconjunctiva can for example be contacted (e.g., gripped) using aconjunctival template device and moved as described above. Theconjunctiva can be rotated so that angular locations of the markings arechanged from their pre-movement marked angular positions. In FIG. 7 cthe tissue treatments can be formed in both the conjunctiva and scleraat locations corresponding to the post-movement positions of themarkings as described above, and in FIG. 7 d the conjunctiva can bemoved as described above. Subsequently, the tissue treatments in theconjunctiva can be closed as discussed above. Modified embodimentssimilar to those discussed above in connection with FIGS. 5 a-5 e may beimplemented, as well.

FIGS. 8 a-8 d depict a particular implementation of the process of FIGS.7 a-7 d, wherein a pair of tissue treatment markings is formed on theconjunctiva at zero, ninety, one hundred and eighty, and two hundred andseventy degrees. In the implementation depicted in FIG. 8 a, a diameterof the cornea is about 16 mm and the tissue treatment markings of eachpair are spaced about 3 microns apart. In FIG. 8 b the conjunctiva isrotated or torqued in the clockwise direction about twenty to thirtydegrees. In FIG. 8 c the tissue treatments are formed in both theconjunctiva and sclera at locations corresponding to the post-movementpositions of the markings as described above, wherein the tissuetreatments in the conjunctiva comprise apertures disposed at eachangular location (e.g., each post-movement angular location) andcorresponding tissue treatments in the underlying sclera compriseelongated shapes (e.g., elongated kerfs) extending radially outwardly atconstant or substantially constant angular positions. In the illustratedembodiment, the tissue treatments of each pair in the sclera have widthsof about 2 mm and are spaced about 1 mm apart. In FIG. 8 d theconjunctiva is rotated or torqued in a counter-clockwise directiontwenty to thirty degrees back to its naturally-occurring orientation,followed by the tissue treatments in the conjunctiva being closed asdiscussed above.

With reference to FIGS. 9 a-9 d, a rotation process is shown whereintissue treatment markings are formed on the conjunctiva at exemplarylocations of zero, ninety, one hundred and eighty, and two hundred andseventy degrees. As depicted in FIG. 9 a, the locations for generationof tissue treatments can be disposed on the conjunctiva in sets (e.g.,pairs). One or more (e.g., all) of the sets can comprise, for example, aplurality of tissue treatments or tissue treatment groupings asdescribed above. Similarly to the embodiment of FIGS. 7 a-7 d, thetissue treatment markings (and/or tissue treatments) on or in theconjunctiva comprise reduced sizes relative to the corresponding tissuetreatment markings (and/or tissue treatments) of, for example, FIG. 1.According to one aspect, the tissue treatment markings (and/or tissuetreatments) in the conjunctiva comprise reduced sizes relative tocorresponding tissue treatments that will be formed therebeneath in thesclera. As presently shown, markings for the tissue treatments or tissuetreatment groupings of each set are spaced one from the other atdifferent (e.g., greater) distances than for example those shown in FIG.5 a. In the illustrated embodiment, the tissue treatment markingscomprise aperture shapes disposed at each angular location (e.g., eachpost-movement angular location) where a corresponding tissue treatmentor tissue treatment grouping will be formed in the sclera. Furthermore,in exemplary embodiments markings for the tissue treatments or tissuetreatment groupings of one or more of the sets are configured to allowinterweaving of corresponding tissue treatments or tissue treatmentgroupings in the conjunctiva with one or more of the subsequently formedtissue treatments or tissue treatment groupings in the sclera. In theillustrated embodiment, markings for the tissue treatments or tissuetreatment groupings of each set allow interweaving of tissue treatmentsor tissue treatment groupings in the conjunctiva with each of thesubsequently formed tissue treatments or tissue treatment groupings inthe sclera (cf. FIG. 9 d, infra).

In FIG. 9 b the conjunctiva is moved (e.g., rotated or torqued) orshifted in some way or to some degree as described above. Theconjunctiva can for example be contacted (e.g., gripped) using aconjunctival template device and moved as described above. Theconjunctiva can be rotated so that angular locations of the markings arechanged from their pre-movement marked angular positions and, aspresently illustrated, so that the post-movement angular location(s) ofat least one of the markings of each set is disposed between two of thepre-movement locations of the markings of a corresponding set. Accordingto the implementation illustrated in FIG. 9 b, the post-movement angularlocation of one or more of the markings of each set is disposed betweentwo of the pre-movement marking locations of the corresponding set. InFIG. 9 c the tissue treatments can be formed in both the conjunctiva andsclera at locations corresponding to the post-movement positions of themarkings as described above. The tissue treatments or tissue treatmentgroupings can be formed in the conjunctiva to have reduced sizesrelative to the corresponding tissue treatments or tissue treatmentgroupings in the underlying sclera. As presently embodied, the tissuetreatments or tissue treatment groupings formed in the conjunctivacomprise reduced sizes (e.g., apertures) and the tissue treatments ortissue treatment groupings in the underlying sclera comprise elongatedshapes (e.g., elongated kerfs) extending radially outwardly at constantor substantially constant angular positions. In FIG. 9 d the conjunctivacan be moved (e.g., moved back) as described above, after which thetissue treatments in the conjunctiva can be closed as discussed above.Modifications may be implemented similar to those discussed above inconnection with FIGS. 5 a-5 e.

FIGS. 10 a-10 d depict a particular implementation of the process ofFIGS. 9 a-9 d, wherein a pair of tissue treatment markings is formed onthe conjunctiva at zero, ninety, one hundred and eighty, and two hundredand seventy degrees. In the implementation depicted in FIG. 10 a, adiameter of the cornea is about 16 mm and the tissue treatment markingsof each pair are spaced about 4 microns apart. In FIG. 10 b theconjunctiva is rotated or torqued in the clockwise direction about sevento twelve degrees, so that following the procedure tissue treatments inthe conjunctiva will be interweaved with subsequently formed tissuetreatments in the sclera and the tissue treatments in the sclera willnot be exposed.

In FIG. 10 c the tissue treatments are formed in both the conjunctivaand sclera at locations corresponding to the post-movement positions ofthe markings as described above, wherein the tissue treatments in theconjunctiva comprise apertures and corresponding tissue treatments inthe underlying sclera comprise elongated shapes (e.g., elongated kerfs)extending radially outwardly. In the illustrated embodiment, the tissuetreatments of each pair in the sclera have widths of about 2 mm and arespaced about 2 mm apart. In FIG. 10 d the conjunctiva is rotated ortorqued in a counter-clockwise direction seven to twelve degrees back toits naturally-occurring orientation, followed by the tissue treatmentsin the conjunctiva being closed as discussed above.

FIG. 11 a is a perspective view of FIG. 5 c, and FIG. 11 b is aperspective view of FIG. 5 d. FIG. 12 a is a perspective view of FIG. 7c, and FIG. 12 b is a perspective view of FIG. 7 d. Regarding theaperture-shaped tissue treatment markings (and/or tissue treatments) on(in) the conjunctiva, the sizes and shapes of these items can be formed,for example, to be as small as possible while still enabling, forexample, formation of corresponding tissue treatments or tissuetreatment groupings therebeneath in the sclera.

In the illustrated embodiment, the tissue treatment markings on andtissue treatments in the conjunctiva comprise circular shapesapproximating the cross-section of (e.g., and formed by) a fiber optictip that can, in the illustrated embodiment, be used to form the tissuetreatments in the underlying sclera. Formation of tissue treatments inthe conjunctiva and sclera using a laser as depicted in FIG. 12 a can beaccomplished using various apparatuses and techniques, exemplaryapproaches including one or more of: (a) separating the conjunctiva fromthe sclera by injecting a fluid such as an epinephrine-based fluidtherebetween via a needle entry point in a vicinity of the limbus; (b)inserting a fiber optic tip through a tissue treatment locatedapproximately midway along a length of an underlying tissue treatment(e.g., elongated kerf) or tissue treatment grouping (e.g., collection ofrelatively small tissue treatments approximating, or bounded by, shapesof the illustrated elongated kerfs) and then forming the tissuetreatment or tissue treatment grouping in the sciera by, for example,changing an orientation of the fiber optic tip as shown in thecross-sectional view of FIG. 12 a; and (c) inserting a fiber optic tipthrough a tissue treatment located in a vicinity anywhere between(and/or including) the limbus and a point midway along a length of anunderlying tissue treatment or tissue treatment grouping.

An exemplary implementation of the (a) approach can comprise a surgeonselecting a minimum amount of anesthesia needed to keep the patientcomfortable, with the anesthesia comprising at least one of thefollowing local anesthetics: 1% Tetracaine applied in a circular ringpledget around the ciliary body for five minutes; local subtenon'sinjection with 2% Lidocaine applied one quadrant at a time; and topical2% Xylocalne gel applied 20-30 minutes prior to surgery. Topical 1%Proparacaine can be applied 5 minutes before the procedure andperiodically during the procedure as deemed appropriate by the surgeonaccording to the patient's pain response. Topical 1% Tetracaine or 2%Lidocaine can also be used. A peribulbar injection comprising a 50/50mixture of 2% Lidocaine with 0.75% Marcaine can be administeredaccording to the clinical judgment of the investigator if the patientdoes not obtain effective anesthesia by any of the above methods. Onedrop of a topical antibiotic (Vigamox, Ciloxan or Zymar) and one drop ofa topical non-steroidal anti-inflammatory (Acular LS or Voltaren) canalso be applied. The patient can be prepared according to typicalprotocols for refractive surgery, with a lid speculum being insertedfollowed by placement of a cornea protector over the cornea.

Eight inter-muscular limbal markings may then be formed 1:30, 4:30,7:30, and 10:30 o'clock positions, followed by performance of a fomixbased peritomy. If needed, cautery may be used for hemostasis. Also, ifneeded, the surgeon may form one or more of the marks once again to maptissue treatment (e.g., incision) locations in each quadrant. Tworadially orientated marks can be formed in a quadrant area 0.75 mm fromthe limbus (the point where the iris can no longer be seen through thecornea), with each of the two marks being extended approximately 5 mm inlength posteriorly over the ciliary body and stopping anteriorly to thepars plana and with a 2.5 mm separation between each mark.

Two corresponding tissue treatments (e.g., incisions) in the markedquadrant area can then be generated, wherein scleral tissue is ablatedto about 95% of a total thickness (e.g., approximately 500-550 microns)of the sciera. The incisions can be generated using an Er, Cr:YSGG laserhaving a frequency of 30 Hz, a wavelength of 2.78 microns, and a spotsize of 600 microns. The surgeon can watch for the characteristic darkblue hue of choroid as an endpoint during each ablation process. Theabove-described steps can be repeated to generate additional pairs ofincisions in the remaining three quadrant areas. Subsequently, each ofthe peritomy sites can be closed with bipolar forceps, sutures orTisseal glue, followed by placement of 1 drop NSAID and 1 dropantibiotic thereto. An eye patch or patches may be used only if needed,and the patient can be instructed to use his or her eyes for normal nearand far vision immediately following surgery.

The (b) approach, with or without inclusion of part or all of the (a)approach, is exemplified in FIGS. 12 a and 12 b. A typicalimplementation of the (c) approach, with or without any part of (a)included, can comprise forming a tissue treatment in the conjunctiva ator near the limbus and then advancing a fiber optic tip, and/or othertissue treatment forming device, distally away from the limbus to adistal (i.e., furthest from the limbus) end of the tissue treatment ortissue treatment grouping that subsequently will be formed in thesclera. The fiber optic tip is advanced beneath the conjunctiva, and inthe illustrated embodiment is advanced between the conjunctiva and thesclera. Movement of the fiber tip beneath the conjunctiva can followeither or both of the following two methods, at least in part and in anycombination or permutation. According to one method, as the fiber tip isadvanced distally it can be activated/operated to form the tissuetreatment or tissue treatment grouping that is to be formed in thesclera and/or, according to another method, the fiber tip can beadvanced (e.g., advanced fully) to the distal end of the tissuetreatment or tissue treatment grouping that is to be formed in thesclera and then retracted proximally while being activated/operated toform the tissue treatment or tissue treatment grouping in the sclera.

FIGS. 13 a and 13 b are perspective views of FIGS. 6 c and 6 d,respectively; and FIGS. 14 a and 14 b provide perspective views of FIGS.9 c and 9 d, respectively.

Regarding the tissue treatment markings and/or tissue treatments on andin the conjunctiva and/or sclera, these items can be formed as describedpreviously in connection with FIG. 12 b.

Other examples of repositioning the conjunctiva can include shifting, asdistinguished from the above-illustrated examples depicting rotating,all or at least a part of the conjunctiva, relative to the sclera,before application of the tissue treatments. In certain implementations,some or all of the parts of the conjunctiva located above portions ofthe sclera receiving tissue treatments are shifted rather than, inaddition to, and/or using techniques similar, analogous or substantiallythe same as any one or more of the above-described rotating treatments.With reference to FIG. 3, a part or all of the conjunctiva can begripped using a conjunctival template device and shifted a slightdistance in, for example, the x-axis 40 direction, such as, for example,a distance of up to 90 degrees. In other implementations, the distancemay range from about 0 to about 90 degrees, and/or different portions ofthe conjunctiva may be shifted, for example, at different points intime, in different directions and/or different distances. Following thegripping and shifting of part or all of the conjunctiva a slightdistance in the x-axis 40 direction as presently described, theconjunctiva can be held in the shifted position by using theconjunctival template device while some or all of the tissue treatmentsare applied. After application of some or all of the tissue treatments,the conjunctiva can be moved (e.g., shifted) back, to a full or partialextent, to its naturally-occurring orientation by using a conjunctivaltemplate device and/or can be released (e.g., by removal of a grippingor holding device or devices) so that the conjunctiva assumes, in fullor in part, its naturally-occurring orientation.

In connection with any of the rotations and/or shifts of the conjunctivadescribed herein, and/or at any pre-operative or intermediate step, partor all of the conjunctiva being altered may be treated to, for example,control bleeding.

A method that may be used to control bleeding is described in U.S.Provisional Application No. 60/591,934, filed Jul. 27, 2004 and entitledMEDICAL LASER HAVING DUAL-TEMPERATURE FLUID OUTPUT, the entire contentsof which are expressly incorporated herein by reference. According tothe referenced method, cooled matter (e.g., fluid) may be applied toreduce bleeding by way of an encouragement of constriction of bloodvessels. The cooled matter (e.g., air and/or water below roomtemperature) may be applied to a tissue, for example, to controlbleeding, which bleeding may have been caused by cutting, ablating, orother trauma inflicted on the tissue. Such cooled matter (e.g., fluid,gel, ice pack) may be applied, for example, to an eye to slow or stopbleeding following an ablation procedure, such as a cutting procedureperformed with a laser. As examples, cooled matter may be appliedbefore, during, or after any of the steps described herein that maycause bleeding. For instance, cooled matter may be applied to the eye inconnection with procedures involving rotating or shifting theconjunctiva.

Care may be taken when rotating or shifting the conjunctiva to attenuatetissue damage, such as de-vascularization and/or necrosis, resultingfrom, for example, excessive movement of the conjunctiva. In certainembodiments, portions of the conjunctiva to be moved may be separatedfrom underlying tissue using known techniques, to thereby facilitategreater movement of the conjunctiva while controlling tissue damage.According to certain implementations, a fluid, such as anepinephrine-based fluid (e.g., anesthetic and/or vasal constrictor) maybe introduced (e.g., in a vicinity of a boundary of the conjunctiva andone or more of the cornea, the choroid, and the ciliary muscle) beforesubstantial movement and/or before separation from underlying layers ofthe conjunctiva. In modified embodiments, the fluid may have a viscositygreater than water. For instance, the fluid may comprise a gel, such asa transparent, water based gel.

Following any of the rotations and/or shifts of the conjunctivadescribed herein, and/or at any intermediate step, part or all of theconjunctiva being altered may be held with any known temporary orpermanent means. For example, following movement back to, or back to andthen slightly beyond, its naturally-occurring orientation, sutures,surgical tacks, screws or staples, and/or applinator-style attachmentsincluding adhesives may be applied to hold the conjunctiva in place.

Torquing or rotating of the conjunctiva may be possible using any of avariety of methods and devices. While being formed almost entirely ofcollagen, the conjunctiva is vascular and thus should be handledcarefully, for example, to minimize bleeding. The conjunctiva may alsobe capable of being extensively stretched. Regarding movement of theconjunctiva (cf. FIG. 5 b), as presently illustrated, the conjunctivacan be rotated using, for example, a tool, so that the angular locationsof the markings are changed from their initial (i.e., pre-movement)marked angular positions. Following such movement (e.g., rotation), theconjunctiva may be held in the post-movement position using, forexample, a conjunctival template device while some or all of the tissuetreatments are subsequently applied.

Before torquing the conjunctiva, the conjunctiva may be, for example,ballooned with a fluid. For instance, a fluid (e.g., comprisingepinephrine) may be inserted beneath the conjunctiva, to therebyseparate the conjunctiva from the underlying sclera. According to oneaspect of the present invention, a pair of incisions (e.g., top andbottom incisions) may be formed in the conjunctiva, and a tool having apair of opposing legs may be inserted between the conjunctiva and thesclera. FIGS. 15 a and 15 b depict an embodiment of such a tool 61having a pair of opposing legs 63 and 65. FIG. 15 a is a side-elevationview of the tool 61, and FIG. 15 b provides a top planar view of thetool 61 taken from a perspective of line 15 b-15 b′ of FIG. 15 a. Thelegs 63 and 65 comprise intermediate portions 67 and 69, respectively,and lower portions 71 and 73, respectively.

During use, the lower portions 71 and 73 can be inserted through theincisions of the conjunctiva so that they contact and rest upon thesclera and so that the intermediate portions 67 and 69 remain in andcontact sidewalls of the incisions. In typical embodiments, dimensionsof the pair of incisions can correspond to cross-sectional shapes of theintermediate portions 67 and 69 so that the intermediate portions 67 and69 rest snugly within and contact the sidewalls of the incisions, but,on the other hand, so that sizes of the incisions are minimized to avoidunnecessary trauma to the conjunctiva.

As the tool 61 is rotated about a rotational axis 75, the lower portions71 and 73 slide over (e.g., contacting or not contacting) the sclera andthe intermediate portions 67 and 69 contact and apply rotational forcesto the sidewalls of the incisions to thereby move (e.g., rotate) theconjunctiva. The tool 61 can thus be used to torque the conjunctiva in afirst direction. Incisions can then be lased, for example, on oppositesides of each leg (to thereby form 4 incisions) with the incisionspenetrating into and forming tissue treatments in the sclera. Theconjunctiva may then be torqued further in the same direction followedby formation of additional tissue treatments in a similar manner, and/ormay be torqued in a second direction opposite to the first followed tofacilitate formation of additional tissue treatments in a similarmanner. The torquing and tissue treatment forming processes may berepeated in any order. In a particular example, bottom and top incisionsmay be made in the conjunctiva in its original orientation at 90 and 270degrees (respectively, 6 o'clock and 12 o'clock).

The tool legs 63 and 65 then may be inserted into the bottom and topincisions. The tool 61 then may be used to torque the conjunctiva in aclockwise direction by, for example, 45 degrees. Two kerfs may be lasedon either side of each leg, followed by the conjunctiva being torqued 90degrees about the rotational axis 75 in a counter-clockwise directionopposite to the first direction to a position 45 degreescounter-clockwise from the original orientation of the conjunctiva,whereby two kerfs again may be lased on either side of each leg. Theconjunctiva then may be torqued to its original orientation followed byremoval of the tool, or the tool may be removed and the conjunctivaallowed to assume its original orientation or some other orientation.When the conjunctiva assumes its original orientation, the procedurejust described results in four double kerfs located at 45, 135, 225, and315 degrees on the polar coordinate system introduced above. That is,four double kerfs are located at northeast, northwest, southwest, andsoutheast positions of the eye relative to, for example, a pupil thatdefines an origin for the polar coordinate system and a polar axis (e.g.east or zero degrees) as illustrated by polar axis 38 in FIG. 1.

According to implementations of the method just described, aconjunctival template device may be employed to facilitate the formationof tissue treatments under the conjunctiva. FIGS. 16 a and 16 b arepictorial diagrams showing, respectively, perspective and side-elevationviews of an embodiment of a conjunctival template device 90. Theillustrated embodiment of the conjunctival template device 90 mayinclude a built-in template 92 comprising, for example, one or moreslots 94 that may be used for positioning the tissue treatments (e.g.,incisions) in a region 96 of the conjunctiva and/or sclera.

The built-in template 92 may comprise four arm implements disposed at 0,90, 180 and 270 degrees, and the slots 94 may comprise one or more slotsdisposed in each arm implement, such as, for example, two parallel slotsdisposed in each arm implement or, as shown, an ‘H’ shape of two slotsdisposed in each arm implement. Tissue treatments or tissue treatmentgroupings may be formed under the conjunctiva corresponding to theshapes of the slots, or may have reduced sizes (e.g., formed by anoutput tip as apertures having sizes that are about the same as across-sectional area of the output tip) with the tissue treatments ortissue treatment groupings in the underlying sclera comprising, forexample, elongated shapes (e.g., elongated kerfs) extending radiallyoutwardly at constant or substantially constant angular positions (cf.FIGS. 12 a and 14 a). Thus, an aperture-shaped tissue treatment may beformed in the conjunctiva under a center region of each slot, andelongated tissue treatments may be formed in the sclera under andcorresponding in shape to each slot.

In embodiments wherein the two slots (e.g., parallel slots) in each armimplement are partially connected by a relatively small transverse slotto form an “H-shaped” slot in each arm implement, an output tip, such asa cylindrically-shaped sapphire laser output tip, can be inserted intothe transverse slot and through (e.g., via formation of a smallincision) the conjunctiva so that the output tip rests, for example,between the conjunctiva and the sclera. To facilitate the insertions ofthe output tip through the conjunctiva in vicinities of (e.g., betweenpairs of) treatment areas, tissue treatments (e.g., aperture-shapedtissue treatments having shapes corresponding to a cross-sectional shapeof the output tip) may be formed in the conjunctiva corresponding innumber and position to the transverse slots. Following placement of theoutput tip between two parallel slots in a center area of a transverseslot, and through an aperture-shaped tissue treatment of theconjunctiva, the output tip can be moved in a first direction in thetransverse direction (e.g., the direction parallel to an elongate axisof the transverse slot) into a first one of the two slots and can bemoved in a second direction opposite to the first direction into asecond one of the two parallel slots.

According to an aspect of the present invention, the conjunctivaltemplate device can be held in a fixed position relative to the eye(e.g., relative to the cornea), so that movement of the output tip in agiven direction tends to move the conjunctiva (e.g., a portion of theconjunctiva in a vicinity of the output tip) in the given direction. Forexample, the conjunctival template device can be held in a fixedposition relative to the eye by way of a cornea (and/or limbus)contacting portion of the conjunctival template device engaging aportion of the eye in a vicinity of the cornea to resist rotation of theconjunctival template device. For instance, a structure comprising atemplate guide, such as a built-in template, can be placed (e.g.,secured with suction), for example, to the limbus and contain or provideindications pertaining to one or more of proper locations, sizes andshapes (e.g., lengths) of tissue treatments, and may also contain adepth guide.

Suction may be applied to the contacting portion, wherein the contactingportion may be constructed and operated as described in connection withFIGS. 19 a-19 c. In one illustrative example, movement of the output tipfrom the center area of the transverse slot in the first direction movesthe conjunctiva (e.g., a portion of the conjunctiva) in the firstdirection and movement of the output tip from the center area of thetransverse slot in the second direction move the conjunctiva (e.g., aportion of the conjunctiva) in the second direction. According toanother illustrative example, movement of the output tip from the centerarea of the transverse slot in the first direction moves a portion ofthe conjunctiva a corresponding (e.g., approximately equal) distance inthe first direction, and movement of the output tip from the center areaof the transverse slot in the second direction moves a portion of theconjunctiva a corresponding (e.g., approximately equal) distance in thesecond direction. Thus, in accordance with an aspect of the presentinvention, the conjunctiva can be moved (e.g., rotated or torqued) orshifted in two opposing directions to facilitate formation of twodifferent tissue treatments in the underlying sclera.

In a particular example wherein an output tip is inserted through anaperture-shaped tissue treatment of the conjunctiva beneath a centralregion of an H-shaped slot, the output tip can be moved (moving aportion of the conjunctiva in the same direction with it) into a firstone of two slots forming the H-shaped slot, at which time the output tipcan form an elongated tissue treatment as described previously withreference to FIGS. 12 a and 14 a. The output tip then can be moved backthrough the central region of the H-shaped slot and then moved (carryinga portion of the conjunctiva in the same direction with it) into theother parallel slot, at which time another elongated tissue treatmentcan be formed in the same manner as described previously. The output tipthen can be moved back to the central region of the H-shaped slot andwithdrawn from the aperture-shaped tissue treatment. Subsequently, thesingle (e.g., circular shaped) tissue treatment in the conjunctivabetween the two elongated tissue treatments in the sclera can be closedusing, for example, bipolar forceps, sutures and/or glue. In a modifiedembodiment, coagulating energy may be applied to the tissue treatmentregions before or during formations thereof.

Constructions, operations, and modifications, of and to thisconjunctival rotating device can be similar at least in part to,substantially the same as, or identical to, that described above. Forexample, a centrally-disposed contacting portion of the conjunctivalrotating device may be constructed and operated as described above sothat suction can be applied to hold the contacting portion to thecornea. An output tip can be inserted through an aperture-shaped tissuetreatment of the conjunctiva beneath a central region of the window,followed by movement of the output tip in the first direction to thesame location as described above and formation of an elongated tissuetreatment in the same place and manner as discussed above, followed bymovement of the output tip in the second direction to the same region asdescribed above and formation of an elongated tissue treatment in thesame manner and position as discussed above.

In other embodiments, an applinator device can be placed on a surface ofthe eye, for example, to drain or force-out blood and/or to attenuate orrestrict blood flow. For example, perspective and side-elevation viewsof an embodiment of an applinator device 100 are shown in FIGS. 17 a and17 b, respectively, and an underside perspective view of the applinatordevice 100 is shown in FIG. 18. The illustrated embodiment of anapplinator device 100 may substantially cover and/or seal-off all orpart of an area of an eye 104 being treated. The applinator device 100may comprise a suction ring 102 around a periphery of the applinatordevice 100, the suction ring 102 acting to provide an effective sealwith a surface of the eye 104.

According to one implementation, suction is applied to provide atourniquet-like effect on the conjunctiva so that pooling of liquids(e.g., blood) is attenuated or eliminated. One implementation comprisespositioning an applinator device with suction in a vicinity where theblood vessels come to rest on the eye. The embodiment further comprisesa tube 106 being fabricated in the illustrated embodiment as part of thesuction ring 102. Blood or other fluids may be held away from atreatment area; and/or blood or other fluids collecting, for example,between the surface of the eye 104 and the applinator device 100 may bedrawn off through the tube 106 when suction is applied to the tube 106from an external source. The applinator device 100 may serve as a guide(e.g., a stencil or template) for the positioning and/or formation oftissue treatments (e.g., incisions), wherein the suction may act, forexample, to secure the applinator device 100 to the eye 104 during thoseprocedures.

Alternatively, or additionally, a handle may be used to secure theapplinator device 100 to the eye 104 during the same or similarprocedures. In modified embodiments, the applinator device may comprisemarkings and/or may comprise openings for the above-described feet 63and 65 (FIGS. 15 a and 15 b). The exemplary configuration of anembodiment of an applinator device 100 illustrated in FIGS. 17 a and 17b can comprise a template 103 having slots (e.g., arcuate slots) at theabove-described northeast, northwest, southwest, and southeast positionsconfigured for use as described herein. For instance, tissue treatmentsor tissue treatment groupings may be formed in the conjunctivacorresponding to at least parts of the shapes of the slots, or may havereduced sizes (e.g., formed by an output tip as apertures having sizesthat are about the same as a cross-sectional area of the output tip)with the tissue treatments or tissue treatment groupings in theunderlying sclera comprising, for example, elongated shapes (e.g.,elongated kerfs) extending radially outwardly at constant orsubstantially constant angular positions. The illustrated embodimentcomprises a template 103 incorporating “H-shaped” apertures 118configured for use as described herein. For example, tissue treatmentsor tissue treatment groupings may be formed in the conjunctivacorresponding to or reduced in size relative to the shapes of the slots,with the tissue treatments or tissue treatment groupings in theunderlying sclera comprising, for example, elongated shapes.

FIGS. 19 a-19 c depict an embodiment of a conjunctival displacementdevice 122. Top perspective bottom perspective, and side-elevation viewsof the conjunctival displacement device 122 are provided in FIGS. 19 a,19 b, and 19 c, respectively. The conjunctival displacement device 122may be employed to facilitate, for example, one or more of displacementof the conjunctiva and placement of tissue treatments into the sclera.An illustrated embodiment of the conjunctival displacement device 122includes a contacting portion 125 and one or more arm implements 127.According to an exemplary embodiment, the contacting portion 125 can beconstructed, for example, to contact a central part of the eye such asthe cornea and/or limbus, and the one or more arm implements 127 can beconstructed for facilitating positioning on a non-central part of theeye such as over the conjunctiva and sclera.

In a modified embodiment, the contacting portion 125 may be, in whole orin part, non-centrally disposed and/or configured not to contact thecornea and limbus. For example, the contacting portion may alternativelyor additionally comprise a suction ring and tube, such as the suctionring 102 and tube 106 depicted and described in connection with FIGS. 17a and 17 b. Typical implementations of this modified embodiment maystill comprise an arm implement or implements constructed to rotateabout a central portion of the device (e.g., about a central portion ofthe eye), but wherein this central portion of the device may or may notnecessarily contact the eye as a result of, for example, the suctionring providing a contact. Such typical implementations thus may comprisecentrally-disposed portions that are similar to the contacting portion125, with a difference being that the modified centrally-disposedportions do not contact the cornea or limbus.

Support arms may be provided, for example, extending from the modifiedcentrally-disposed portion to the suction ring to thereby support thecentrally-disposed portion above the surface of the eye. One or moresupport bridges (e.g., two support bridges disposed 180 degrees apart)may be provided, for example. To the extent the support bridges impedeoptimal (e.g., 180 or 360 degree) rotation of the one or more armimplements, two or more arm implements may be provided and/or templates(infra) may be provided on each of the arm implements. In an embodimentcomprising two arm implements, each being disposed, for example, 180degrees from the other and comprising a template, rotation of the twoopposing arm implements can provide an effective or optimal angularrange of movement to the arm implement pair.

As presently embodied, the arm implement 127 includes a user aid orguide comprising, for example, at least one template 132 that may beused for positioning tissue treatments (e.g., incisions) in regions ofthe conjunctiva and/or sclera. As presently embodied, the template 132may comprise, for example, an “H-shaped” slot, or, as another example,two slots (e.g., parallel slots).

Constructions, operations, and modification, of and to the conjunctivaldisplacement device 122 can, at least in part, be similar to orsubstantially the same as that described above. For instance, thecontacting portion 125 of the conjunctival displacement device 122 maybe provided with a tube 135, which may be constructed and operated inwhole or in part as described above, with reference to for example tube106, including application of suction via, for example, tube 135 tofacilitate securement or fixation of the contacting portion 125 to theeye. The tube 135 can be fabricated in the illustrated embodiment as aseparate or integral part of the contacting portion 125. When the tube135 is used in combination with the contacting portion 125, and when,for example, suction is applied to the tube 135 from an external source,the combination of tube 135 and contacting portion 125 may facilitatethe provision of one or more of the following: resist shifting forcesimparted onto the contacting portion 125; resist rotational forces aboutthe center axis 129 that may be imparted onto the contacting portion125; provide an effective seal with one or more of the cornea and limbusof the eye; hold blood or other fluids away from a treatment area; anddraw blood or other fluids off through the tube 135. Alternatively, oradditionally, a handle may be used to secure the conjunctivaldisplacement device 122 to the eye during the same or similarprocedures.

According to one aspect of the present invention, alignment indicia 141are disposed on the contacting portion 125 for aiding a user in aligningthe conjunctival displacement device 122 and, more particularly, thecontacting portion 125 to facilitate placement of tissue treatments. Ina typical implementation, the user may align top and bottom alignmentindicia 141 with south and north (i.e., 90 and 270 degree) directions ofthe eye and/or align right and left alignment indicia 141 with east andwest (i.e., 0 and 180 degree) directions, or right and left corners, ofthe eye.

According to another aspect of the present invention, positionengagement structure is provided on one or more of the contactingportion 125 and the arm implement 127. As embodied herein, the positionengagement structure comprises indentations 144 disposed atpredetermined locations on the contacting portion 125 and protuberances146 disposed on the arm implement wherein the protuberances 146 aresized and shaped for rotation-inhibiting engagement with theindentations 144. The arm implement 127 may be provided as a single armimplement, comprising structure and elements as depicted and/or furthercomprising position engagement structure as described above, or the armimplement 127 may be provided in combination with a secondary armimplement 128.

Provision of the arm implement 127 as a single implement may beaccomplished with or without protuberances being affixed to the armimplement 127 for rotation-locking engagement with correspondingindentations of the contacting portion. Typical embodiments may furthercomprise a secondary arm implement 128, which may comprise protuberancesaffixed to the secondary arm implement for rotation-locking engagementwith corresponding indentations of the contacting portion. For instance,in certain embodiments, such as illustrated in the drawings, only thesecondary arm implement 128 may be provided with protuberances to theexclusion of the arm implement 127. While one or more arm implements 127may be provided, alone or in combination with one or more secondary armimplements 128, certain illustrated embodiments such as elucidated inthe figures can comprises a pair consisting essentially of one armimplement 127 (e.g., without protuberances) and one secondary armimplement 128 (e.g., with protuberances) being provided on eachcontacting portion 125.

In modified embodiments, two or more arm implements 127 (e.g., withoutprotuberances) may be provided with one secondary arm implement 128(e.g., with protuberances) on each contacting portion 125. Otherembodiments may comprise two or more arm implements 127 (e.g., disposed180 degrees apart). For instance, two or more arm implements 127 may beprovided, without any secondary arm implements 128, on each contactingportion 125, wherein one or more of the arm implements 127 comprisesprotuberances. In particular implementations, a single one, or both, ofthe arm implements 127 may be provided with protuberances.

When, for example, the contacting portion 125 comprises acentrally-disposed contacting portion 125, the arm implement 127 may berotatable, or removable and securable in different angular positions,about the centrally-disposed contacting portion 125. In typicalembodiments, the arm implement 127 may be constructed, using anymaterial and structure known to those skilled in the art to be suitableor operable for such purposes, to be rotatable about a center axis 129of the contacting portion 125.

Embodiments comprising one or more arm implements 127 and one or moresecondary arm implements 128 may comprise connecting structure coupledbetween one or more of the arm implements 127 and one or more secondaryarm implements 128. In an example, the connecting structure can comprisea connecting ring 131, disposed concentrically about the center axis andlinking rotational movement of the arm implement 127 to rotationalmovement of the secondary arm implement 128. In a particular example,the connecting ring 131 fixes rotational movement of the arm implement127 to rotational movement of the secondary arm implement 128, so thatrotational movement of either one of the arm implement 127 and thesecondary arm implement 128 results in corresponding (e.g., identical)rotational movement of the other of the arm implement 127 and thesecondary arm implement 128. Thus, in this example, the arm implement127, the secondary arm implement 128, and the connecting structure(e.g., connecting ring 131) are all connected and together can berotated, relative to the contacting portion 125. In other embodiments,connecting structure is omitted, in whole or in part, so that one ormore of the arm implements 127 is not coupled to one or more of thesecondary arm implements 128.

In exemplary embodiments, rotation of the arm implement 127, relative tothe contacting portion 125 that is fixed onto the eye, facilitatesrotation or movement of the conjunctiva. At least one conjunctiva tonguecan be positioned, for example, on each arm implement for gripping andmoving at least a local portion of the conjunctiva according to typicalembodiments. In the illustrated embodiment, two conjunctiva tongues 138can be positioned on the arm implement 127, and further can bepositioned on opposing sides of the arm implement 127 as depicted, forexample, in FIG. 19 b.

In use, a gripping incision (not shown) can be formed in the conjunctivato accommodate either one of the conjunctiva tongues 138. A size andshape of the gripping incision can be predetermined or varied accordingto a size and shape of the conjunctiva tongue or tongues. For example,in an embodiment as shown in FIG. 19 a wherein the conjunctiva tongue138 has an edge with a length, as measured in a direction d1, of about 6mm, the gripping incision may be formed in the conjunctiva to have acomplementary or accommodating shape with a length of about 10 mm asmeasured in a direction parallel to the direction d1.

The one of the two tongues that is disposed on a leading edge of the armimplement 127, when the arm implement 127 is rotated in a clockwisedirection, can be inserted into a gripping incision followed by rotationin the clockwise direction of the arm implement by a predeterminedangular amount whereby the movement invokes a corresponding movement ofthe conjunctiva in the same direction to the same or a lesser degree.For example, the arm implement 127 may be rotated (e.g., about 45degrees) in the clockwise direction until a protuberance on thesecondary arm implement 128 lockingly engages with a correspondingindentation 144 in the contacting portion 125, at which time one or moretissue treatments may be formed as described above.

The two proximal ends (i.e., located closest to the tube 135) may thenbe pinched or otherwise moved toward one another (e.g., pinchedtogether) to release the protuberance 146 from engagement within theindentation 144 and to facilitate additional rotation. For example, theadditional rotation may comprise a rotation (e.g., about 45 degrees) inthe opposite (e.g., counter-clockwise) direction until the one tonguecan be removed from the gripping incision and the other one of the twotongues can be inserted into the same gripping incision, followed bycontinued rotation in the counter-clockwise direction of the armimplement by a predetermined angular amount whereby the movement invokesa corresponding movement of the conjunctiva in the same direction to thesame or a lesser degree.

For example, the continued rotation of the arm implement 127 in thecounter-clockwise direction may comprise a continued rotation of about45 degrees until a protuberance on the secondary arm implement 128lockingly engages with a corresponding indentation 144 in the contactingportion 125, at which time one or more tissue treatments may be formedas described above. The two proximal ends (i.e., located closest to thetube 135) may again be moved toward one another to release theprotuberance 146 from engagement within the indentation 144 andoptionally to facilitate additional rotation. At this point, tissuetreatments may have been formed, for example, in southwest and southeastquadrants of the sclera. In a similar manner, tissue treatments mayfurther be formed in northeast and northwest quadrants of the sclera.

In accordance with one aspect of the present invention, one or moreconjunctiva catches can be provided on the arm implement. Eachconjunctive catch may comprise, in typical embodiments, a conjunctivacollecting ridge 148. In modified embodiments, other embodiments (e.g.,of different shapes, sizes and locations on the arm implement) ofconjunctiva catches may be formed, alone or in combination with theillustrated, or modified, conjunctiva collecting ridges. Moreover, theone or more conjunctiva catches can be provided on corresponding armimplements alone or in combination with the one or more conjunctivatongues.

As presently embodied, the number of conjunctiva catches providedcorresponds to the number of conjunctiva tongues disposed on each armimplement. According to typical embodiments, each conjunctiva catch isdisposed between a conjunctiva tongue and a template of a correspondingarm implement to catch and/or carry portions of the conjunctiva as thearm implement is rotated. For instance, a conjunctiva collecting ridgecan prevent conjunctival tissue from moving up and over into thetemplate as the arm implement is rotated.

Regarding anti-rotational structures or properties of the contactingportion, according to certain aspects of the present invention, one ormore paws (not shown) may be provided to reach back in a directionmeasured from the cornea to the retina and to contact a gripping regionof the eye for facilitating a securement of the contacting portion. Thesecurement may operate to resist or prevent shifting or rotationalmovement of the contacting portion. Embodiments incorporating one ormore paws may be implemented alone or in combination with embodimentswherein suction (e.g., via a tube) is employed to facilitate securementof the contacting portion. Each paw may comprise a size tailored to fita size of the patient's eye and/or may comprise, for example, a polymersuch as polymethylmethacrylate (PMMA). Each paw further may be providedas part of an arm implement or a secondary arm implement or may beformed to extend individually back to the gripping region. Shapes ofpaws may take on various forms such as wedge shapes, and surfaces ofpaws may comprise tiny cleats, barbs, corrugations, ribs, suction cups,adhesives, or other devices for producing a gripping action between asurface or layer of the eye and the paw as known to those skilled in theart.

In certain embodiments, a paw, such as, for example, an inter-layer paw,may be secured between two layers of the eye, such as between theconjunctiva and the sclera. The inter-layer paw may have any of thestructures and functions discussed previously, such as a wedge shape,and further may comprise, for example, an expandable material that canfacilitate an increase or change in size along at least one dimension ofthe inter-layer paw after positioning thereof in a gripping region. Inone example, the paw may comprise an inflatable wedge, which can beinserted or otherwise positioned in a vicinity of a gripping region andthen pumped (e.g., via a line and/or reservoir that can be squeezed by ahand of a user to direct fluid into the paw, with, for example, onesqueezable line being provided for each paw) with water or air forpurchase. A regulator or release valve may be provided to prevent overinflation of the paw. In other embodiments, rather than beinginflatable, one or more of the paws may comprise an expandable material,such as an expandable foam that may be flattened or otherwise reduced insize before insertion, wherein following insertion (e.g., 10-15 secondsfollowing insertion) and positioning in a gripping region, the pawexpands under its own memory and returns to an original size. For anyembodiments employing a paw, it may be advantageous to have at least oneof the surfaces of the paw configured as a low-friction surface tofacilitate insertion and/or positioning of the paw and, subsequently, tohave at least one surface of the paw configured as a relativelyhigh-friction surface to facilitate gripping of the paw to the eye. Tothis end, specialized surfaces (e.g., relatively nonporous surfaces thatare lubricated using, for example, viscasil®, to facilitate relativelylow-friction insertion and that subsequently, as a consequence of beingrelatively nonporous for example, become relatively high-frictionsurfaces) may be implemented as are known to those skilled in the art.

In accordance with other configurations of the present invention,template or slot locations can comprise “stops” that physically orvisually provide or facilitate stopping indications or functions to theupper portions 77 and 79 and/or to a surgeon's torquing and/ortissue-treatment forming actions. For instance, the stops may operate tolimit torquing movement by the tool 61 to plus or minus 45 degree rangesof motion.

The applinator device can be fabricated, for example, as part of aspeculum. In one embodiment, the applinator device may be constructedwith a plurality of hook-like members, which members may operate toprovide the functionality of a speculum.

Suction may be provided, as well, by operation of the applinator device.In exemplary implementations, the applinator device may be constructed(e.g., at a time of manufacture or via manipulation or configuration ofthe applinator device at a time of application to the eye) to providesuction in a vicinity of connective tissue of the eye.

Connective tissue is determined by the placement of the muscles and thetissue that is attached to the muscles. It is believed that theconnective tissue is located at the superior fomix of the conjunctiva,so that application of suction using a suction ring may reduce thesupply of blood to the conjunctival tissue. Suction may be provided onthe underside of the applinator device in typical embodiments, whereinfor example a contacting portion of the applinator device is fixed andprovides the suction, and wherein for example a template portion of theapplinator device can be rotated. A piezoelectric or other motor devicecan be provided in certain implementations to automatically facilitateapplication of cuts along, for example, each template or slot and/or toautomatically move the applinator device through predetermined ranges ofmotion for positioning and/or provision of tissue treatments. In certainimplementations, such suction may be implemented to contact andfacilitate movement and/or separation (e.g., lifting) of the conjunctivafrom the sclera.

In other embodiments and implementations, the conjunctival displacementdevice 122 (FIGS. 19 a-19 c), or any previous device such as theconjunctival template device 90 (FIGS. 16 a-16 b), can be constructed sothat the two slots (e.g., parallel slots) in each arm implement aresubstantially entirely connected by a relatively large slot (e.g.,having the same length as that of the two parallel slots) to therebyform a single rectangular-shaped slot or window in each arm implement,as shown, for example, in FIGS. 24 a-24 c.

In other embodiments, the single rectangular-shaped window in each armimplement can have the same or a greater length than the two parallelslots but a reduced width, such as shown in FIG. 20, wherein a singlenarrow channel is formed in each arm implement or in a single armimplement if only one is used. With reference to that figure, the narrowchannel 151 can provide a greater and/or different visibility of areassurrounding a procedural site. In accordance with another aspect, thearm implement 153 may be operated with a smaller footprint on theconjunctiva than other devices. For example, the arm implement 153 canbe provided with two conjunctiva tongues 155 positioned on, for example,opposing sides of the arm implement 153, for fitting into a single-slotincision 157 rather than two incisions or an enlarged I-shaped incision(cf. FIG. 28, infra).

One of the conjunctiva tongues 155 can be placed into the single-slotincision during the formation of each of two tissue treatments, or bothof the conjunctiva tongues 155 can be placed into a single-slot incisionat the same time for the formation of each corresponding tissuetreatment. According to one aspect of the present invention, each tissuetreatment may be formed in the conjunctiva corresponding to the shape ofthe narrow channel, or may have a reduced size (e.g., formed by a fiberoptic tip as an aperture having a size that is about the same as across-sectional area of the fiber optic tip) with the tissue treatmentin the underlying sclera comprising an elongated shape (e.g., elongatedkerf) extending radially outwardly at a substantially constant angularposition and approximating the shape of the narrow channel 151. In thisembodiment or any of the embodiments described herein, the mentionedaperture which can be formed in the conjunctiva may be formed in alocation corresponding to the posterior part of the window, slot, ornarrow channel, so that, for example, a patient's eyelid will be morelikely to cover the fiber-optic-tip entry point (i.e., the mentionedaperture) following the procedure.

Regarding the referenced FIGS. 24 a, 24 b and 24 c, a conjunctivaldisplacement device 222 is provided with a contacting portion 225 (e.g.,a cornea suction cup formed of silicon) and a handle 230, which canserve as a positioning tool or stem. Typical implementations of thisembodiment may comprise a first arm implement 227 and a second armimplement 228, each being disposed, for example, 180 degrees from theother and comprising a template, wherein rotation of the two opposingarm implements can provide an effective or optimal angular range ofmovement to the arm implement pair.

An upper, rotatable portion 231 of the conjunctival displacement device222 is fixed to the first arm implement 227 and the second arm implement228. The handle 230, on the other hand, is fixed (e.g., integrallymolded into the cup of the contacting portion 225) to the contactingportion 225. A nub 232 of the handle 230 fits into three indentations233 a, 233 b and 233 c formed by rounded teeth, which three indentationscorrespond to the three orientations assumable by the handle 230.

In modified embodiments, the nub may comprise a shape of a cylinder,which is oriented, for example, to have its longitudinal axis generallyparallel with a rotational axis of the upper, rotatable portion 231, sothat an arcuate surface of the cylinder fits into complimentary-shapedsurfaces of the three indentations 233 a, 233 b and 233 c. The cylinderor other similar structure may be referred to as an indexing detent,which, as with the nub 232 embodiment, can be integrally molded into thecontacting portion 225.

The first arm implement 227 and the second arm implement 228 may each bereferred to as a laser guide paddle, which pivots between and locks inthree positions each separated by 45 degrees as presently embodied.Also, the templates of the first arm implement 227 and the second armimplement 228 may be referred to as swivel-lock templates.

Referring to FIG. 24 b, a gap 237 permits the nub 232 to be deflected asit swivel-indexes the teeth. This figure also depicts in phantom thelocations of two tissue treatments to be formed beneath the conjunctivain the sclera according to an outline of the window of the first armimplement 227.

The handle 230 may be coupled to the upper, rotatable portion 231 of theconjunctival displacement device 222 at various angular orientations.For instance, as illustrated with particular reference to FIG. 24 a, thehandle 230 can be secured at a central orientation, as shown, and canalso be secured at two secondary orientations angularly disposed at plusor minus 45 degree orientations from the central orientation.

Being fixed to the contacting portion 225, movement of the handle 230 toeither of the two secondary orientations results in correspondingrotational movement of the first arm implement 227 and the second armimplement 228.

In one favored implementation, the handle 230 is not fixed to the upper,rotatable portion 231 of the conjunctival displacement device 222.Instead, part or all of the handle 230 is fixed (e.g., integrallymolded) into the contacting portion 225, or is removably securedthereto. Here, the rounded teeth forming the three indentations 233 a,233 b and 233 c, can be integrally formed with or otherwise affixed to(i.e., rotationally fixed relative to) the upper, rotatable portion 231.Also, the nub, cylinder or other similar structure 232 can be integrallymolded into the contacting portion 225.

The handle 230 may optionally be constructed to comprise a vacuum tube234, which may be constructed and operated in whole or in part asdescribed above, with reference, for example, to tube 106 or tube 235.The vacuum tube 234 can be disposed within the handle 230, wherein thehandle can lead to and be coupled to a caliper mount.

In one implementation, the handle 230 is formed with two large fingers(c.f. left side of FIG. 30) for attaching to calipers. Also, the vacuumtube 234 can comprise a vacuum tube fitting 241 as shown in FIG. 24 c.The perspective underside view of the conjunctival displacement device222 depicted in FIG. 24 c elucidates an opening of the vacuum tube 234,which may be referred to as a vacuum port and which is formed togenerate a flush-surface opening on an inner surface of the contactingportion 225.

According to embodiments comprising a vacuum tube 234, the corneasuction cup of the contacting portion 225 can be formed of anelastomeric material and can be mounted to the cornea via an applicationof vacuum pressure from the vacuum tube 234. In this and otherembodiments comprising a source of vacuum, the source of vacuum canserve as an aspiration source for removing unwanted fluids which mayaccumulate during a procedure.

In addition to the handle 230, a twist tool 235 may be provided in theform of, for example, a rigid or semi-rigid loop. Ends of the twist tool235 can be removably inserted into two twist-tool receptacles 237 a and237 b, for enabling application of rotational forces to the upper,rotatable portion 231. In particular, a first end of the twist tool 235fits into a first twist-tool receptacle 237 a, and a second end of thetwist tool 235 fits into a second twist-tool receptacle 237 b.

Other implementations may omit the twist tool, nub, indentations, and/orrelated structure, such as, for example, embodiments wherein aconjunctival displacement device is provided with a contacting portionthat is coupled to a first arm implement, a second arm implement, athird arm implement and a fourth arm implement. One or more (e.g.,preferably all) of the first arm implement, second arm implement, thirdarm implement and fourth arm implement may be rotationally fixed,relative to the contacting portion.

The first arm implement, second arm implement, third arm implement andfourth arm implement may be angularly spaced, one from another, evenly(e.g., having center points separated one from another by 90 degrees),and may be referred to collectively as a four quadrant template/laserguide.

With reference, for example, back to FIG. 19 c, any of the armimplements described herein can be configured to be disposed on (e.g.,in contact with) or within (e.g., by way of one or more conjunctivatongues) an incision of the conjunctiva. In other embodiments, withreference, for example, to the side-elevation view of FIG. 31 b, infra,any of the arm implements described herein can additionally, oralternatively, be configured to be disposed a relatively small distanceabove the conjunctiva and/or sclera surfaces, such as, for example, adistance of about 1.5 mm. This distance can allow for ballooning of theconjunctiva above the sclera, as shown in FIG. 31 b.

In accordance with one implementation of the invention, a tool and/ortechnique can be provided for placement into contact with theconjunctiva, for example, in the center of a template or window of anarm implement, after which the tool can move (e.g., by suction-grippingand lifting) the conjunctiva away from the sciera, along with filling ofthe space created between the conjunctiva and sclera with fluid,followed by or coupled with a securing of an eyelet or other spreaderimplement, described infra, to the conjunctiva (e.g., an eyelet can besecured with conjunctiva tongues in a neutral or central portion of thewindow).

Any of these types of arm-implement embodiments can be used with orwithout conjunctiva tongues. In particular implementations, whereinconjunctiva tongues are not formed on the arm implements or are formedbut not used, and wherein the arm implements are configured either tocontact or to hover above the eye surface, eyelets may be constructedand used within the windows (e.g., templates) formed by the armimplements.

While the eyelets of the present invention may be operated with anywindow or template configuration, and any corresponding arm-implementstructure disclosed herein, one particular implementation is elucidatedwith reference to FIG. 25. In that figure, a rectangular-shaped window267 is provided in an arm implement 269. In accordance with one aspect,the arm implement 269 may be sequentially positioned in fourtissue-treatment site quadrants, and in accordance with another aspecttwo matching arm implements may be provided with the combined structurebeing rotatable to assume two positions so that all of the fourquadrants may be covered by the two arm implements. In yet anotherembodiment, four arm implements may be provided as disclosed herein.

FIG. 26 a depicts an eyelet 245 for use within a window of an armimplement. A body 247 of the eyelet 245 can comprise an aperture 263 orother torque-application structure, which, in turn, can accommodate arotational device 265. In the illustrated embodiment, the aperture 263comprises a hexagonal inner wall, and the rotational device 265comprises a complementary hexagonal shaft. FIG. 26 b provides a crosssectional view of the eyelet 245 of FIG. 26 a, after the eyelet 245 hasbeen inserted and secured within the conjunctiva 266. Followinginsertion of the eyelet through the conjunctiva 266, and securing (e.g.,sealing and/or conjunctiva-tongue expanding) thereof within theconjunctiva 266, the rotational device 265 can be removed from itsoperative torque-applying position within the aperture 263 leaving theeyelet 245 in place. In other embodiments, the aperture 263 may beformed to have different shapes, such as circular, oval (e.g., to matcha profile of the output tip of FIG. 22), or otherwise. Similarly, therotational device 265 may be formed to have different shapes,complementary or not, or may be omitted altogether.

The eyelet 245 comprises one or more conjunctiva tongues 249. In theillustrated embodiment, the conjunctiva tongue 249 comprises acontinuous spiral shape with a penetrating (e.g., piercing and cutting)leading edge 251. The leading edge and/or other parts of the conjunctivatongue 249 (e.g., all edges) are preferably sharpened. The conjunctivatongue 249 can be formed to have other configurations, such as, forexample, tabs, as depicted in FIG. 25. In FIG. 25, an eyelet 255 isformed with four equally-spaced, rounded tabs for insertion into agripping incision 261 formed in the conjunctiva.

During a procedure, at any given point in time, one or more of therounded-tab conjunctiva tongues 257 can be inserted (e.g., fastened)into a gripping incision. Thus, one, two, or, preferably, all of therounded-tab conjunctiva tongues 257 can be inserted into a grippingincision 261 prior to a lasing step of a procedure. Similarly, theconjunctiva tongue 249 of FIG. 26 a can be inserted into a grippingincision of, or can self-tap a gripping incision and be inserted into,the conjunctiva.

Prior to, commensurate in time with, or immediately following, insertionof the eyelet 255 into the gripping incision 261, portions of theconjunctiva likely to be affected (e.g., with excess bleeding) may betreated with, for example, an electro-surgery laser having green oryellow wavelengths, a vasoconstrictor, or electro-pinchers. The eyelet255 may comprise, for example, one or more (e.g., four) conjunctivatongues 249 that can be folded, bent, or otherwise brought into alow-profile configuration to thereby facilitate insertion of the eyelet255 through a gripping incision 261. Furthermore, the conjunctivatongues 249 may in typical implementations be brought to, or returnedto, by way of, for example, unfolding or unbending, a higher-profileconfiguration after the eyelet 255 has been inserted within, orotherwise secured to, the conjunctiva.

In one embodiment, the eyelet 255 can comprise a generally circularshape as shown in FIG. 25, and can be formed of a stretchable orbendable material which enables the eyelet 255 to be pinched orotherwise deformed into a lower-profile (e.g., oval) shape, while notcollapsing, for facilitation of an insertion (e.g., and/or tucking) ofthe conjunctiva tongues 257 into the gripping incision 261. Pinching ofthe eyelet 255 may be accomplished by, for example, positioning theeyelet 255 over the gripping incision 261 such that a plane of theeyelet 255 is generally parallel to a surface of the conjunctiva at thegripping incision (i.e., in the orientation depicted in the figure), andthen contacting two opposing points 277 and 279 of the body 247, and/orof the conjunctiva tongue(s) 257, of the eyelet 255. A distance betweenthe forceps can then be reduced to generate a reduction in the distancebetween the two opposing points 277 and 279. Reduction of the distancebetween the two opposing points 277 and 279 results, in turn, indeformation of the eyelet 255 and, more particularly, results in acorresponding change in the profile of the eyelet 255 so that theinsertion profile of the eyelet 255 more closely corresponds to aprofile of the gripping incision 261.

The ensuing insertion of the eyelet 255 into the gripping incision 261may thus be performed in a manner less disruptive to the conjunctivaltissue or in a manner requiring a smaller gripping incision 261.Following such insertion of the eyelet 255 into the gripping incision261, the eyelet pinching or deformation force can be removed from theeyelet 255 (e.g., from the two opposing points 277 and 279), therebyenabling the eyelet 255 to return to its former (e.g., circular) shape,whereby an added level of fixation is thus provided to the eyelet 255within the gripping incision 261 as the conjunctiva tongue(s) 257, whichin some embodiments may comprise fewer or more continuous ordiscontinuous tongues encircling the eyelet 255, expand beneath thesurface of the conjunctiva.

With the aperture 263 of the eyelet 245 free from the presence of anyrotational device 265 (e.g., to the extent used) following removalthereof, and with the conjunctiva tongue 249 securing the eyelet 245 tothe conjunctiva 266, the aperture 263 of eyelet 245 can accommodate afiber optic tip 268 of a laser handpiece 271 as depicted in FIG. 26 b.Similarly, with reference to FIG. 25, after the eyelet 255 has beensecured to the conjunctiva, the aperture 272 of the eyelet 255 canaccommodate a fiber optic tip 273 of a laser handpiece 275. In certainimplementations, the aperture 263 or the aperture 272 can be formed toaccommodate one or more of the output tips depicted in FIGS. 21, 22 and23, wherein such output tips may be formed of different components,proportions, or dimensions, and may be formed with or without barbs 163,but wherein, according to certain embodiments, the outer shape of agiven output tip (e.g., or fiber optic tip) complementarily matches aninternal profile of the corresponding aperture (e.g., 263 or 272).

In accordance with an aspect of the present invention, the open aperture263 or 272 can serve as a portal for ablating procedures on theunderlying sciera, and can also serve as a portal for visualizing (e.g.,by way of a fiber optic camera) or other monitoring of the procedure orsite (e.g., tissue treatment site) beneath the conjunctiva. Upon aninitial insertion of, for example, a fiber optic tip within the aperture263 or 272, the aperture may or may not extend in an unobstructedfashion (e.g., not obstructed by parts defining the gripping incision)through the conjunctiva. To the extent it does not, laser or mechanicalenergy or forces may be applied to open the aperture to a degree whichis suitable for the application at hand. The aperture 263 or 272 canalso serve as a portal for interfacing with the windows or templates ofarm implements during ablating procedures on the underlying sclera, sothat relatively accurate and consistent tissue treatments can begenerated. Furthermore, the aperture 263 or 272, when accommodating afiber optic tip or output tip therein, in addition to providing a portalfor tissue-treatment formation and viewing of the tissue-treatmentformation (e.g., by way of a fiber optic camera as disclosed herein),can also serve as a portal for providing blood aspiration (e.g., by wayof an aspiration source coupled to the fiber optic tip or output tip,such as one of the tips disclosed in FIG. 21, 22 or 23), all within aminimally sized incision (e.g., gripping incision) in the conjunctiva.

By way of placement and operation of the output tip or, preferably, thefiber optic tip, of a laser handpiece within the aperture 263 or 272 ofthe eyelet 245 or 255, while the eyelet is secured to the conjunctiva,movement forces can be applied to the eyelet 245 or 255. These movementforces can be provided by way of, for example, pressure being applied tointernal walls of the aperture 263 or 272 by the fiber optic tip.Movement of the fiber optic tip can thus result in varying magnitudesand directions of forces (e.g., pressure) being applied to the eyelet245 or 255, resulting in movement forces that can move the eyelet 245 or255. A user thus can tailor the movement forces to direct the eyelet 245or 255 over one or more predetermined patterns, such as an H-shapedpattern or the pattern shown in phantom in FIG. 24 b, within a window ortemplate of an arm implement. Since the eyelet 245 or 255 is attached tothe conjunctiva, movements of the eyelet 245 or 255 will result incommensurate movements of the gripping incision formed within theconjunctiva. Consequently, one or a plurality of relatively large tissuetreatments can be formed beneath a minimally-sized gripping incision inthe conjunctiva (e.g., as the conjunctiva adjacent to the grippingincision is stretched and compressed) within a given template or windowof an arm implement. A fiber optic tip thus can be placed within theaperture of an eyelet secured to a conjunctiva (e.g., centered within anarm-implement window), and the fiber optic tip can then be traced over apattern (e.g., moved along guide edges of the window) to form one ormore tissue treatments, bringing the eyelet and conjunctiva along withit through the pattern tracing.

Regarding movements of the conjunctiva, the conjunctiva tongues 249 and257 can be disposed on the corresponding eyelets 245 and 255,respectively, for gripping and moving at least a local portion (e.g., aportion within an arm-implement widow within which the eyelet issecured) of the conjunctiva according to typical embodiments. In use, alocation (e.g., a gripping incision 261 location) can be identified forplacement of the eyelet. The location can be, for example, in a neutralor central location of the arm-implement window so that pulling anddistorting of the conjunctiva (e.g., in an H-shaped pattern) results inrelatively uniform distortion of the conjunctiva in the differentrelevant directions). The identified location can correspond to asubsequently-placed gripping incision, formed either before orcommensurate in time with insertion of the eyelet into the conjunctiva.

Various shapes and sizes of gripping incisions can be formed in theconjunctiva to accommodate various forms of conjunctiva tongues. Forexample, a size and shape of the gripping incision can be predeterminedor varied according to, for example, a size and shape of the conjunctivatongue or tongues. For instance, in an embodiment as shown in FIG. 25,wherein a the eyelet may have a diameter of, for example, about 3 mm, apair of the conjunctiva tongues 257 may be formed to have a similar or,preferably, a slightly larger maximum dimension, such as about 3.5 mm.In this example, the gripping incision may be pre-formed in theconjunctiva to have a complementary or accommodating shape (e.g., astraight, linear incision) with a maximum dimension (e.g., length) ofabout 7 mm, or in other embodiments, may be formed in a straight-lineshape of about 4 mm (e.g., for insertion of just two of the tabs orparts of the tongue(s) corresponding to about half of less of the eyeletcircumference), or in another embodiment, formed in a semicircle shape(cf. incision of FIG. 31 a) with a length measured in a straight-linefrom beginning to end of the incision of about 3.5 mm (e.g., forinsertion of just two of the tabs or parts of the tongue(s)corresponding to about half of less of the eyelet circumference).

In another embodiment, the eyelet may have a diameter of, for example,about 1.25 mm, a pair of the conjunctiva tongues may be formed to have asimilar or, preferably, a slightly larger maximum dimension, such asabout 1.5 mm, and the gripping incision may be pre-formed in theconjunctiva to have a complementary or accommodating shape (e.g., astraight, linear incision) with a maximum dimension (e.g., length) ofabout 2.5 mm, or in other embodiments, may be formed in a straight-lineshape of about 2.0 mm (e.g., for insertion of just two of the tabs orparts of the tongue(s) corresponding to about half of less of the eyeletcircumference), or in another embodiment, formed in a semicircle shapewith a length measured in a straight-line from beginning to end of theincision of about 1.75 mm (e.g., for insertion of just two of the tabsor parts of the tongue(s) corresponding to about half of less of theeyelet circumference).

FIGS. 27 a and 27 b show another embodiment of an eyelet 281 with athree-post design, comprising a conjunctiva tongue 283 having a sharpleading edge 285. An optical fiber tip 287 can be inserted through acenter portion of the eyelet 281, and the eyelet 281 can furthercomprise a vacuum tube fitting 289. The perspective underside view ofthe eyelet shown in FIG. 27 b depicts openings 291 that are in fluidcommunication with the vacuum tube fitting 289. The openings 291 can beformed to generate a flush-surface opening, coupled with a fluid passagepath 293, on an undersurface of the eyelet 281. In certainimplementations, the structure 283 may function, in whole or in part, asan eye-surface suction cup to be mounted to the eye via an applicationof vacuum pressure from the openings 291 alone or in combination withthe structure 283 being inserted into a gripping incision within theconjunctiva. In accordance with modified implementations, the eyelet 281can be provided with an enlarged size and/or operated withoutarm-implement windows or templates.

FIGS. 28 a and 28 b show a single-post embodiment of an eyelet 302,comprising a conjunctiva tongue (or, alternatively/additionally,eye-surface suction cup structure) 304 which may comprise a sharpenedleading edge 306. An optical fiber tip 308 can be inserted through acenter portion of the eyelet 302, and the eyelet 302 can furthercomprise a vacuum tube fitting 311. The perspective underside view ofthe eyelet 302 shown in FIG. 28 b depicts an opening 313 that is influid communication with the vacuum tube fitting 311. The opening 313can be coupled with a fluid passage path 315 on an undersurface of theeyelet 302.

FIGS. 29 a and 29 b show an embodiment of an incision spreader 321having a single-post design and, in one implementation, comprising atleast one conjunctiva tongue 323. The incision spreader 321 can serve asa convenient laser guide paddle or arm implement. In an illustratedembodiment, two conjunctiva tongues 323 may be provided on opposingsides of the incision spreader 321. The incision spreader 321 thus maycomprise, as shown, two conjunctiva tongues 323, with each of theconjunctiva tongues 323 having a relatively sharp leading edge forfitting into, for example, a gripping incision formed within theconjunctiva. The incision spreader 321 can further comprise a vacuumtube fitting 331 for supplying negative pressure via a single-postaspiration tube to openings 325. In preferred implementations, thestructure containing the elements 323 may function, in whole or in part,as an eye-surface suction cup or mechanism to be mounted to the surfaceof the eye via an application of vacuum pressure from the openings 325disposed on an underside of the incision spreader 321.

Following securing of the incision spreader 321, by way of, for example,conjunctiva tongues 323 and/or suction provided by way of the vacuumtube fitting 331 to the openings 325, an optical fiber tip and/or eyelet(not shown) can be used to perform operations within the template orwindow 324 of the incision spreader 321. In accordance with certainembodiments, the incision spreader 321 can be provided with an enlargedsize and, preferably, is operated without any other arm-implementwindows or templates besides that 324 provided by its own structure. Inthe illustrated example, a cornea contacting cup 327 can be providedwith indicia 329 disposed thereon for providing incision locations orreference axes 333. Incisions, such as, for example, gripping incisionsas discussed herein, or, in other implementations, I-beam incisions 326such as illustrated in the figure, may be disposed in the conjunctiva ata location or locations corresponding to the indicia 329.

FIG. 30 shows a modified embodiment of the three-post design depicted inFIGS. 27 a and 27 b, wherein a single conjunctiva tongue 341 can beprovided, and FIGS. 31 a and 31 b illustrate an embodiment of the threepost-design having four conjunctiva tongues 343 resembling those of FIG.25. Spaces between the conjunctiva tongues 343 can serve as vents, whichmay, for example, prevent the eyelet from adhering to the sclera underrelatively high (e.g., momentarily high) vacuum forces which may begenerated during a procedure.

FIGS. 32 a and 32 b show an embodiment of a wound spreader 341, whichmay comprise structures similar to and which may operate similarly tothe incision spreader 321. For example, the wound spreader 341 maycomprise a single-post design, a pair of opposing conjunctiva tongues(and/or eye-surface suction cup structure) 343, and a template or window345 within which, for example, an optical fiber tip and/or eyelet (notshown) can be used to perform operations allowing the wound spreader 341to operate as a laser guide paddle or arm implement. The wound spreader341 can be formed (e.g., molded) of a material (e.g., porex) that wicksliquids (e.g., blood) in the directions of the arrows A1 and A2 up intoa stem or handle portion 348 of the wound spreader 341 to therebyfacilitate a relatively blood-free work site for impartation of tissuetreatments. Thus, the wound spreader 341 may be constructed without avacuum tube fitting.

An incision spreader 351 as depicted in FIGS. 33 a and 33 b can compriseor correspond to any one or more of the elements provided in theembodiments of FIGS. 29 a, 29 b, 32 a or 32 b, with a primary element ofthis construction being an open-front 353 design of the template orwindow 355. The open-front 353 can provide additional working space andvisibility.

According to modified embodiments, groupings of tissue treatments of thepresent invention may be disposed around cuts (e.g., kerfs) to thesclera implemented in accordance with other technologies. In othermodified embodiments, as an alternative or addition to any of theembodiments described herein, tissue treatments may be arranged toapproximate or resemble prior-art surgical-formation shapes. Forinstance, tissue treatments may be applied to resemble, or incombination with, correctional patterns as described in U.S. Pat. No.6,263,879, the contents of which are expressly incorporated herein byreference. In implementations wherein tissue treatments of the presentinvention are applied in combination with one or more of the patterns orablation patterns disclosed in the aforementioned patent, the tissuetreatments can be disposed for example along part or all of theboundary(ies) of the linear ablation pattern(s) with or without theablation pattern(s) being formed as well. In modified embodiments, anyof the above tissue treatments may be applied in combination with anyother eye treatments to the extent compatible, or modifiable to becompatible, by one skilled in the art, with the present tissuetreatments. For instance, the presently-described alterations (e.g.,rotations and/or shifts) to the conjunctiva in connection with theformation of tissue treatments in the sclera may be modified and/orcombined with other technologies (e.g., such as described in theaforementioned patent) involving applications or formations oftreatments (e.g., ablations) to the sclera.

The above-described embodiments have been provided by way of example,and the present invention is not limited to these examples. Multiplevariations and modification to the disclosed embodiments will occur, tothe extent not mutually exclusive, to those skilled in the art uponconsideration of the foregoing description. Additionally, othercombinations, omissions, substitutions and modifications will beapparent to the skilled artisan in view of the disclosure herein.Accordingly, it is intended that the present invention not be limited bythe disclosed embodiments, but be defined by reference to the appendedadditional disclosure in claims format.

1. A method for treating an eye having rectus muscles, the eye being inneed of one or more of a physiological and a vision correction, themethod comprising: determining treatment areas of a sclera that are morerigid than other areas of the sclera; and projecting patterns of tissuetreatments onto the treatment areas, each pattern comprising a groupingof tissue treatments and being disposed between a pair of adjacent onesof the rectus muscles.
 2. The method as set forth in claim 1, whereinthe determining is performed by a device.
 3. The method as set forth inclaim 2, wherein the projecting of the patterns of tissue treatmentsonto the treatment areas is performed by the device.
 4. The method asset forth in claim 1, wherein the treatment areas are determining by adevice which scans the sclera to determine the treatment areas.
 5. Themethod as set forth in claim 4, wherein the projecting of the patternsof tissue treatments onto the treatment areas is performed by thedevice.
 6. The method as set forth in claim 2, wherein the device scansthe sclera and determines the treatment areas of the sclera based uponrigidity theory.
 7. The method as set forth in claim 6, wherein theprojecting of the patterns of tissue treatments onto the treatment areasis performed by the device.
 8. The method as set forth in claim 2,wherein the determining comprises marking of the treatment areas by thedevice.
 9. The method as set forth in claim 2, wherein the projecting ofthe patterns of tissue treatments onto the treatment areas is performedby the device.
 10. The method as set forth in claim 9, wherein thegroupings comprise (a) a first grouping in a first area between a firstand a second rectus muscle, (b) a second grouping in a second areabetween the second and a third rectus muscle, (c) a third grouping in athird area between the third and a fourth rectus muscle, and (d) afourth grouping in a fourth area between the fourth and the first rectusmuscle.
 11. The method as set forth in claim 10, wherein: each of thefour groupings is centered in a corresponding one of the respective fourareas; and each pattern comprises a grouping of at least eight tissuetreatments and is disposed between a pair of adjacent ones of the rectusmuscles.
 12. The method as set forth in claim 9, wherein each patterncomprises a grouping of at least twenty tissue treatments and isdisposed between a pair of adjacent ones of the rectus muscles.
 13. Themethod as set forth in claim 9, wherein the projecting of patterns oftissue treatments onto portions of the eye comprises projecting fourpatterns of tissue treatments onto portions of the eye.
 14. The methodas set forth in claim 9, wherein the tissue treatments of each groupingare arranged in rows and columns.
 15. The method as set forth in claim9, wherein the tissue treatments are formed to depths between about 90%and 99% of a thickness of a sclera of the eye.
 16. The method as setforth in claim 9, wherein the tissue treatments comprise relativelysmall perforations ranging from about 1 micron to about 5 microns indiameter.
 17. The method as set forth in claim 1, wherein: the groupingscomprise one or more relatively sparsely-populated groupings of tissuetreatments that are formed during an initial procedure; and during oneor more follow-up procedures one or more additional tissue treatmentsare projected to alter the one or more relatively sparsely-populatedgroupings of tissue treatments.
 18. The method as set forth in claim 17,wherein the one or more additional tissue treatments more denselypopulate the one or more relatively sparsely-populated groupings oftissue treatments.
 19. The method as set forth in claim 17, wherein theone or more additional tissue treatments change a shape of the one ormore relatively sparsely-populated groupings of tissue treatments. 20.The method as set forth in claim 17, wherein a determination is madebefore the one or more follow-up procedures that an efficacy of the oneor more relatively sparsely-populated grouping(s) of tissue treatmentsis sub-optimal.
 21. The method as set forth in claim 17, wherein adetermination is made before the one or more follow-up procedures thatthe eye may stand to benefit from the introduction of additional tissuetreatments.
 22. The method as set forth in claim 17, wherein the one ormore follow-up procedures are implemented over multiple patient visits.23. The method as set forth in claim 17, wherein the initial andfollow-up groupings of tissue treatments share parts of the sameboundaries as distinguished from groupings having different boundaries.24. The method as set forth in claim 1, wherein the projecting comprisesablating one or more of a conjunctiva and a sciera of the eye.
 25. Themethod as set forth in claim 1, wherein the projecting comprisesprojecting lower intensity tissue treatment energies on the conjunctivathan on the sclera.
 26. The method as set forth in claim 1, wherein theprojecting comprises forming larger tissue treatments on the conjunctivathan on the sclera.
 27. The method as set forth in claim 1, wherein: thedetermining is performed by a device; and the projecting of the patternsof tissue treatments onto the treatment areas is performed automaticallyby the device.
 28. The method as set forth in claim 1, wherein: thetreatment areas are determining by a device which automatically scansthe sclera to determine the treatment areas; and the projecting of thepatterns of tissue treatments onto the treatment areas is performedautomatically by the device.
 29. The method as set forth in claim 1,wherein: the determining is performed by a device; the device scans thesclera and determines the treatment areas of the sclera based uponrigidity theory; and the projecting of the patterns of tissue treatmentsonto the treatment areas is performed automatically by the device. 30.The method as set forth in claim 1, wherein: the determining isperformed by a device; the determining comprises marking of thetreatment areas by the device; and the projecting of the patterns oftissue treatments onto the treatment areas is performed by the device.